Pharmacovigilance Lead Stellenangebote

Job vor 11 Tagen bei NewScientist Jobs gefunden Alkermes

Vice President, Drug Safety Pharmacovigilance

• Waltham, Massachusetts, United States, Waltham Führungs-/ Leitungspositionen Job Description The Vice President of Drug Safety and Pharmacovigilance will provide strategic leadership and operational oversight to ensure the safety and benefit-risk balance of Alkermes investigational and marketed products. This role will be responsible for shaping and advancing the company s Drug Safety and Pharmacovigilance function while fostering strong cross-functional collaboration. Additionally, this leader will serve as a key voice in safety-related decision-making, contributing expertise to regulatory submissions, labeling strategies, and corporate governance. Responsibilities Serve as a pragmatic, strategic leader with a steady, clear voice for Drug Safety and Pharmacovigilance, fostering strong collaboration and high rapport with cross-functional partners Provide clear and effective communication on product safety and benefit risk issues to internal and external stakeholders Actively participate in protocol review and publications review committees, ensuring consistency and appropriate context of safety information provided Oversee all facets of Drug Safety and Pharmacovigilance: Lead ongoing safety medical support for product teams, including safety reviews, adverse event signal detection and product complaint monitoring Ensure timely and accurate generation of aggregate safety reports and responses to regulatory authorities Maintain a proactive benefit-risk strategy for all investigational and marketed products Direct in-house and outsourced safety operations, including global case processing and submissions, safety database management, and department quality, training and compliance functions Oversee epidemiology activities supporting safety signal investigations Drive DSPV staff development, ensuring alignment with departmental and corporate objectives through strategic goal setting, budgeting, and resource planning Serve as Chair of Safety Committee and member of the Labeling Committee (i. e. , Company Core Data Sheets and local labeling) Responsible for final review and sign off [...]
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Neu Job vor 6 Std. bei Jobvector gefunden BioNTech SE Mathematician as Director (m/f/d) • Berlin, 12489 Führungs-/ Leitungspositionen Homeoffice möglich [...] aspects Oversee and give statistical guidance on trials within a platform or portfolio Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables Perform and/or verify sample size calculations, lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results Participate in planning for health authority [...] and infrastructure initiatives and evaluations Support and assist GBS Lead in both strategy developments and operations Mentors (Associate) Directors and/or assumes possible line management responsibilities of staff and is responsible for recruiting, developing, and retaining talent Collaborate with Safety and Pharmacovigilance in developing processes and standards to support safety assessment, signal detection and decision making Provide input into early risk management [...]
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Job vor 2 Tagen bei Jobvector gefunden BioNTech SE

Oncologist as Director (m/f/d)

• Mainz, 55131 Führungs-/ Leitungspositionen Homeoffice möglich (Senior) Director, Clinical Development (m/w/d) London, United Kingdom; Berlin, Germany; Mainz, Germany full time Job ID:6950The Senior Director Clinical Development will work hand-in-hand with the[...]

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[...] Development (m/w/d) London, United Kingdom; Berlin, Germany; Mainz, Germany full time Job ID:6950The Senior Director Clinical Development will work hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization for the assigned programs. He/ She will lead the strategic direction of assigned programs and will be responsible to oversee and provide guidance for the design and execution [...] the assigned programs, in liaison with the responsible program manager. Leads the program core team. Creates and translates Target Product Profile into clinical strategy. As Program Lead, articulates targets of TPP and CDP to other development functions (e. g. Regulatory, Pharmacovigilance, Statistics, etc. ) and drives alignment on objectives and expected outcomes Responsible for study medical/ safety aspects and risk-benefit assessments [...]
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Job vor 2 Tagen bei Jobvector gefunden ITM Isotope Technologies Munich SE Physician, Pharmacist-Pharmacovigilance (m/f/d) • Garching bei München, 85748 Homeoffice möglich Jobticket [...] model in Garching as soon as possible. Deputy Graduated Plan Officer (GPO) / Stellvertretender Stufenplanbeauftragter (f/m/d) Fulfil the role of the GPO during the absence of the appointed GPO, according to the relevant legislation and guidelinesSet up and manage a pharmacovigilance system ( 63a of AMG) Collect and evaluate reports of drug risks and coordinate the necessary measures and responsibility for [...] they relate to drug risks ( 63a of AMG and 19 of AMWHV) Inform the qualified person of the necessary measures ( 19 of AMWHV 14 of the Medicines Act) Inform the competent authority immediately of any defect that could lead to a recall or an unusual restriction on distribution and shall also state the countries to which the medicinal product [...]
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Job vor 2 Tagen bei Jobvector gefunden BioNTech SE

Biologist as Associate Director (m/f/d)

• Mainz, 55131 Führungs-/ Leitungspositionen Homeoffice möglich Jobticket [...] with cross-functional teams. Partner with safety physicians to review and contribute to safety-relevant sections of clinical trial protocols, investigator brochures, clinical study reports, and statistical outputs (tables, figures, listings) , and to co-author relevant safety documentation for BioNTech compounds. Actively lead or contribute to BioNTechs Safety Surveillance Teams (SST) and Safety Management Teams (SMT) , including meetings to ensure consistent safety [...] ethical requirements, and act as a Subject Matter Expert during audits and inspections for core safety processes. Advanced Degree in life sciences, pharmacy, public health or a related field (PhD preferred) Minimum 5 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry, including case processing activities Strong knowledge of applicable regulatory, GCP, and GVP requirements [...]
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Job vor 5 Tagen bei StepStone gefunden ITM Isotope Technologies Munich SE Deputy Graduated Plan Officer (GPO) / Stellvertretender Stufenplanbeauftragter (f/m/d) • Garching bei München, Home- Office Homeoffice möglich Jobticket [...] in Garching as soon as possible. Deputy Graduated Plan Officer (GPO) / Stellvertretender Stufenplanbeauftragter (f/m/d) Fulfil the role of the GPO during the absence of the appointed GPO, according to the relevant legislation and guidelines Set up and manage a pharmacovigilance system ( 63a of AMG) Collect and evaluate reports of drug risks and coordinate the necessary measures and responsibility for [...] they relate to drug risks ( 63a of AMG and 19 of AMWHV) Inform the qualified person of the necessary measures ( 19 of AMWHV 14 of the Medicines Act) Inform the competent authority immediately of any defect that could lead to a recall or an unusual restriction on distribution and shall also state the countries to which the medicinal product [...]

Job vor 8 Tagen bei StepStone gefunden Daiichi Sankyo Europe GmbH

Labeling Strategist (m/f/x) (Global Labeling Strategy Lead)

• europaweit Beratungs-/ Consultingtätigkeiten Homeoffice möglich Work-Life-Balance With over 120 years of experience and approximately 19, 000 employees in more than 30 countries/ regions, Daiichi Sankyo is dedicated to discovering, developing, and[...]

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[...] with cancer and their loved ones. Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada. We are seeking highly qualified candidates to fill the position of: Labeling Strategist (m/f/x) (Global Labeling Strategy Lead) The position: This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic [...] member of Global Project Team (GPT) to address labeling issues for late-stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/ leads the maintenance [...]

Job am 19.03.2025 bei StepStone gefunden Bavarian Nordic GmbH Sr. Quality Assurance Expert/ Specialist-GCP (m/f/d) • Martinsried, Kvistgaard, Bern Homeoffice möglich [...] will be reporting to directly to the head of R D QA and be part of a team of a Global Quality Assurance Staff located in Germany, Denmark, Canada and in the US that are supporting GCP, GLP, GCLP and Pharmacovigilance, providing opportunities for cross-functional collaborations and interesting development opportunities. Bavarian Nordic is growing in many aspects and offers an opportunity [...] Support inspection readiness activities Prepare and host inspections from regulatory authorities Maintain and track change control, investigations, deviations and CAPAs to closure Support the development and maintenance of the corporate GCP audit programs Perform internal and external audits as a lead auditor or as a co-auditor Support with oversight over subcontracted contracted audit programs Support development, maintenance and continuous improvement of [...]

Job vor 2 Tagen bei JobMESH gefunden Daiichi Sankyo Europe GmbH Labeling Strategist (m/f/x) (Global Labeling Strategy Lead) Work-Life-Balance [...] with cancer and their loved ones. Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada. We are seeking highly qualified candidates to fill the position of: Labeling Strategist (m/f/x) (Global Labeling Strategy Lead) The position: This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic [...] member of Global Project Team (GPT) to address labeling issues for late-stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/ leads the maintenance [...]

Job vor 8 Tagen bei Mindmatch.ai gefunden ITM Isotope Technologies Munich SE Deputy Graduated Plan Officer (GPO) / Stellvertretender Stufenplanbeauftragter (f/m/d) • garching bei münchen, BY Homeoffice möglich Jobticket ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals[...]

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[...] in Garching as soon as possible. Deputy Graduated Plan Officer (GPO) / Stellvertretender Stufenplanbeauftragter (f/m/d) Fulfil the role of the GPO during the absence of the appointed GPO, according to the relevant legislation and guidelines Set up and manage a pharmacovigilance system ( 63a of AMG) Collect and evaluate reports of drug risks and coordinate the necessary measures and responsibility for [...] they relate to drug risks ( 63a of AMG and 19 of AMWHV) Inform the qualified person of the necessary measures ( 19 of AMWHV 14 of the Medicines Act) Inform the competent authority immediately of any defect that could lead to a recall or an unusual restriction on distribution and shall also state the countries to which the medicinal product [...]

Job am 02.04.2025 bei Mindmatch.ai gefunden Bavarian Nordic GmbH

Sr. Quality Assurance Expert/ Specialist-GCP (m/f/d)

• deutschland Bavarian Nordic-Protecting our tommorow At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial[...]

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[...] will be reporting to directly to the head of R D QA and be part of a team of a Global Quality Assurance Staff located in Germany, Denmark, Canada and in the US that are supporting GCP, GLP, GCLP and Pharmacovigilance, providing opportunities for cross-functional collaborations and interesting development opportunities. Bavarian Nordic is growing in many aspects and offers an opportunity [...] Support inspection readiness activities Prepare and host inspections from regulatory authorities Maintain and track change control, investigations, deviations and CAPAs to closure Support the development and maintenance of the corporate GCP audit programs Perform internal and external audits as a lead auditor or as a co-auditor Support with oversight over subcontracted contracted audit programs Support development, maintenance and continuous improvement of [...]

Job am 31.03.2025 bei Jobleads gefunden Medical Monitor Oncology • München, Bayern PSI is a leading Contract Research Organization with more than 25years in the industry, offering a perfect balance between stability and innovation to both clients[...]

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[...] compliance with the currently approved protocol/ amendments Address safety issues across the study from sites and the study team Supports and/or performs medical data review of the operational clinical trial database Participate in meetings with clients and Investigators Assist in Pharmacovigilance activities Identify Program risks, and create and implement mitigation strategies with Clinical Operations Organize and lead clinical development advisory boards and safety monitoring boards Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines Review [...]

Job am 09.03.2025 bei Jobleads gefunden

Senior Director Biostatistics (Oncology)

Führungs-/ Leitungspositionen [...] aspects. Oversee and give statistical guidance on trials within a platform or portfolio. Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables. Perform and/or verify sample size calculations, lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results. Participate in planning for health authority [...] and infrastructure initiatives and evaluations. Support and assist GBS Lead in both strategy developments and operations. Mentor (Associate) Directors and/or assume possible line management responsibilities of staff and is responsible for recruiting, developing, and retaining talent. Collaborate with Safety and Pharmacovigilance in developing processes and standards to support safety assessment, signal detection and decision making. Provide input into early risk management [...]

Job am 08.03.2025 bei Jobleads gefunden Sales Director Germany (DACH leadership team) • Düsseldorf, Nordrhein- Westfalen Führungs-/ Leitungspositionen Sales Director Germany (DACH leadership team) My client is seeking a dynamic Sales Director to lead and develop sales activities in Germany. This pivotal role is crucial for the companys growth, leveraging exceptional networking skills and [...] to strategic priorities and key programs for the Germany and DACH organisation, ensuring smooth communication and addressing specific problems. Quality Compliance: Ensure all sales activities comply with local regulations and uphold the companys integrity and ethical standards. Ensure compliance with Pharmacovigilance obligations and report any potential code of conduct issues. Qualifications: Bachelors degree or MBA. Long term experience in a similar [...]
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Job am 08.03.2025 bei Jobleads gefunden Senior Director Biostatistics (Oncology) • Mainz, Rheinland- Pfalz Führungs-/ Leitungspositionen [...] aspects Oversee and give statistical guidance on trials within a platform or portfolio Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables Perform and/or verify sample size calculations, lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results Participate in planning for health authority [...] and infrastructure initiatives and evaluations Support and assist GBS Lead in both strategy developments and operations Mentors (Associate) Directors and/or assumes possible line management responsibilities of staff and is responsible for recruiting, developing, and retaining talent Collaborate with Safety and Pharmacovigilance in developing processes and standards to support safety assessment, signal detection and decision making Provide input into early risk management [...]

Job vor 4 Tagen bei Jobleads gefunden Head of Medical Affairs (m/f/d) Germany • Mettmann, Nordrhein- Westfalen Führungs-/ Leitungspositionen Make your mark for patients Are you passionate about making a difference in patients lives? Do you thrive in a dynamic and innovative environment? If[...]

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[...] you passionate about making a difference in patients lives? Do you thrive in a dynamic and innovative environment? If yes, this could be the perfect fit for you: We are looking for a Head of Medical Affairs (m/f/d) Germany to lead a team of managers for patient engagement and solutions, customer care (UCB Cares) , and the medical governance unit, including [...] in close cooperation with the Asset Medical Heads and the GLT, ensuring best-in-class customer experience for KOLs, patients, and physician associations, and healthcare authorities. Organize, oversee, and coordinate the German Pharma Network: Chair the German Pharma Network team consisting of Pharmacovigilance, Quality, Regulatory, Compliance, and Safety. Ensure that all Pharmacovigilance, Safety, Quality, Compliance, and Safety-related risks are appropriately escalated in a [...]
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Job vor 4 Tagen bei Jobleads gefunden

Head of Medical Affairs (m/f/d) Germany

• Mettmann, Monheim, Nordrhein- Westfalen, Bayern Führungs-/ Leitungspositionen [...] you passionate about making a difference in patients lives? Do you thrive in a dynamic and innovative environment? If yes, this could be the perfect fit for you: We are looking for a Head of Medical Affairs (m/f/d) Germany to lead a team of managers for patient engagement, customer care (UCB Cares) , and the medical governance unit including risk management, [...] in close cooperation with the Asset Medical Heads and the GLT, ensuring best-in-class customer experience for KOLs, patients, and physician associations, and healthcare authorities. Organize, oversee, and coordinate the German Pharma Network Chair the German Pharma Network team consisting of Pharmacovigilance, Quality, Regulatory, Compliance, and Safety. Ensure that all Pharmacovigilance, Safety, Quality, Compliance, and Safety-related risks are appropriately escalated in a [...]

Job vor 4 Tagen bei Jobleads gefunden Clinical Outsourcing Director • Sachsen Führungs-/ Leitungspositionen Clinical Outsourcing Director Drug Development Programs Germany-Remote Based We are seeking a Clinical Outsourcing Director to join our fast-paced and mission-driven team. In this strategic[...]

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[...] will oversee all sourcing activities across assigned drug development programs. Youll be responsible for vendor strategy, selection, contracting, and performance oversight, ensuring that external partnerships support program objectives and align with quality, compliance, and cost standards. Key Responsibilities Program Leadership: Lead and manage sourcing team members supporting assigned development programs. Collaborate cross-functionally to contribute to program planning and budgeting, while ensuring [...] field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs/ Writing. We are an equal opportunities Recruitment Business and [...]

Job vor 4 Tagen bei Jobleads gefunden

Senior Manager (m/f/x) Medical Affairs QA

• München, Bayern [...] strategic initiatives in close collaboration with Medical Affairs stakeholders, ensuring the highest ethical standards and quality in interventional, non-interventional, investigator-initiated trials, and managed access programs. This position will report to the Head of Medical Affairs QA. The Associate Director will lead the review of quality and compliance topics, including Key Quality Indicators (KQIs) at Quality Governance Meetings. In close alignment with [...] of global drug development. Demonstrated experience of successfully supporting projects of high impact. Demonstrated agility in a global/ matrix environment. Strong interpersonal skills with demonstrated ability to build collaborative relationships. Thorough and extensive knowledge of ICH-GCP including FDA/ EU regulations, pharmacovigilance, new drug regulations, other key HA guidances and current industry practice. Excellent verbal and written communication skills and computer skills. [...]
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Job vor 4 Tagen bei Jobleads gefunden Sourcing Director Führungs-/ Leitungspositionen Clinical Outsourcing Director Drug Development Programs Location: Germany (remote based) We are seeking a Clinical Outsourcing Director to join our fast-paced and mission-driven team. In[...]

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[...] will oversee all sourcing activities across assigned drug development programs. Youll be responsible for vendor strategy, selection, contracting, and performance oversight, ensuring that external partnerships support program objectives and align with quality, compliance, and cost standards. Key Responsibilities Program Leadership: Lead and manage sourcing team members supporting assigned development programs. Collaborate cross-functionally to contribute to program planning and budgeting, while ensuring [...] field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs/ Writing. We are an equal opportunities Recruitment Business and [...]
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Job vor 6 Tagen bei Jobleads gefunden (Senior) Medical Science Liaison (m/f/x) • Baden- Württemberg Driving Sci Pros strategic client development and commercial strategy across the DACH region for permanent and contract staffing projects. This position is a senior field-based[...]

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[...] (KOL) , disease awareness, and appropriate support of product launches. The (S) MSLs will focus primarily on disease awareness educational programs and gaining insights for Medical Affairs strategy in relevant therapeutic areas. This position works closely with the Country Medical Lead, the Medical Advisor, and colleagues of other functions, e. g. Commercial, Market Access, Health Economic and Outcome Research (HEOR) , Pharmacovigilance, and Regulatory. This visible position will report into the Head of MSL DACH and will be field-based in the country. [...]

Job vor 7 Tagen bei Jobleads gefunden Associate Director Clinical Safety Management (m/w/d) • Frankfurt, Hesse Führungs-/ Leitungspositionen Associate Director Clinical Safety Management (m/w/d) Mainz, Germany full time Job ID:9007 As Associate Director Clinical Safety Management, you will provide scientific and strategic expertise[...]

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[...] with cross-functional teams. Partner with safety physicians to review and contribute to safety-relevant sections of clinical trial protocols, investigator brochures, clinical study reports, and statistical outputs (tables, figures, listings) , and to co-author relevant safety documentation for BioNTech compounds. Actively lead or contribute to BioNTechs Safety Surveillance Teams (SST) and Safety Management Teams (SMT) , including meetings to ensure consistent safety [...] a Subject Matter Expert during audits and inspections for core safety processes. What you have to offer: Advanced Degree in life sciences, pharmacy, public health or a related field (PhD preferred) Minimum 5 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry, including case processing activities Strong knowledge of applicable regulatory, GCP, and GVP requirements [...]

Job vor 7 Tagen bei Jobleads gefunden R D and Pharmacovigilance Compliance Lead • Bulle, Freiburg Führungs-/ Leitungspositionen Make your mark for patients To strengthen our R D and Pharmacovigilance Quality department we are looking for a talented profile to fill the position[...]

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Make your mark for patients To strengthen our R D and Pharmacovigilance Quality department we are looking for a talented profile to fill the position of: R D and Pharmacovigilance Compliance Lead Bulle, Switzerland. About the role As a member of the UCB Quality organization, the R D and PV Compliance Lead [...]

Job vor 7 Tagen bei Jobleads gefunden Senior Manager, Global Labeling Product Leader • Allschwil, Basel- Landschaft Führungs-/ Leitungspositionen At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated,[...]

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[...] new and modified products worldwide in compliance with corporate policies and strategies. Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations. The Senior Manager, Global Labeling Product Leader will be responsible for the following: Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS) , United States Package Insert [...] experience is required. A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required. Relevant experience in the pharmaceutical industry (e. g. , Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc. ) is required. An understanding of pharmaceutical drug development is required. Experience in discussing and communicating scientific concepts is [...]

Job vor 7 Tagen bei Jobleads gefunden Senior Safety Scientist (m/w/d) • Frankfurt, Hesse Mainz, Germany; London, United Kingdom; Munich, Germany full time Job ID:9008 As a Senior Safety Scientist (m/w/d) , you will provide scientific and strategic expertise[...]

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[...] clinical study reports, and statistical outputs (tables, figures, listings) , and to co-author relevant safety documentation for BioNTech compounds. Drive the development, implementation, and continuous improvement of safety signal processes and oversee and enhance safety surveillance across clinical programs. Actively lead or contribute to BioNTechs Safety Surveillance Teams (SST) and Safety Management Teams (SMT) , including organizing and facilitating meetings to [...] a Subject Matter Expert during audits and inspections for core safety processes. What you have to offer: Advanced Degree in life sciences, pharmacy, public health or a related field (PhD preferred) Minimum 5 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry, including case processing activities Strong knowledge of applicable regulatory, GCP, and GVP requirements [...]