Pharmacovigilance Expert Stellenangebote

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16 Stellenangebote

Stellenangebote Pharmacovigilance Expert Jobs bei StepStone

Job vom 02.10.2024 Otsuka Pharma GmbH

Senior Manager, GxP Controlled Document Management (m/f/d)

• Frankfurt am Main Beratungs-/ Consultingtätigkeiten

MEHR

[...] GxP Document Management Participate in internal improvement projects, lead projects as assigned Education in natural science or equivalent number of years experience At least 5 years of pharmaceutical or medical device industry experience, preferably including Quality Management for Gx Ps Expert knowledge and experience in relevant regulations and guidance documents, e. g. in the area of Clinical Development, Medical Devices, IMP management, Regulatory Affairs or Pharmacovigilance Strong expertise with MS Word and MS Teams, including managing teams and channels Working expertise with MS Power Point and [...]
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Stellenangebote Pharmacovigilance Expert Jobs bei Jobleads

Job gestern gefunden

Senior Medical Director Oncology Clinical Development- Solid Tumor

• Schaffhausen Führungs-/ Leitungspositionen

MEHR

[...] CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs) . Serves as an in- house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with [...] key external meetings. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Qualifications Medical Doctor (M. D. ) , [...]

Job vor 8 Tagen gefunden

Medical Affairs Manager

• Zürich

MEHR

[...] meaningful and transformative healthcare solutions. The Role As Medical Affairs Manager, you will be a key contributor to the establishment of the Swiss Ascendis affiliate. You will serve as a crucial link between Ascendis Pharma and the medical community, providing expert insights and facilitating accurate scientific communication. This strategic position plays a central role in aligning our medical strategy with business [...] to the Country Manager, Switzerland. Your Key Responsibilities Leadership Strategy Develop and implement the Swiss medical affairs strategy in alignment with local and corporate goals. Build strong, cross- functional relationships with internal teams (e. g. , Market Access, Marketing, Sales, Pharmacovigilance, Regulatory) to ensure strategic alignment. Collaborate with regional Medical Affairs colleagues to support scientific and strategic initiatives. Monitor competitive activities [...]
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Job vor 8 Tagen gefunden

ED, Development Business Partner

• Bern

MEHR

Position Title (Business Title) : Ex. Director, Development Business Partner Position Purpose: The Executive Director, Development Business Partner will be the strategic advisor for the Clinical, Pharmacovigilance, Regulatory, Real- World Evidence and R D Strategic Operations leaders of the R D organization. They will be responsible for [...] agent in the shift to a Product delivery model. Stakeholder Collaboration: Managing both business and I T stakeholders, ensure successful collaboration and alignment of requirements and solutions enabled by the platform, creating and communicating a coherent and tangible roadmap. Technology Expert: Stay up to date on current trends in the industry as well as within the technology landscape which you are [...]
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Job vor 11 Tagen gefunden

Associate Director, R D Quality Systems, Strategy, and Excellence (International Affiliate)

• Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

[...] to local demands. Through collaboration, data- driven insights, and a risk- based approach, this role drives continuous improvement in quality systems and processes, ensuring global compliance across GCP (Good Clinical Practice) , GMP (Good Manufacturing Practice) , and GVP (Good Pharmacovigilance Practice) . Ultimately, the role is pivotal in fostering a culture of quality excellence, ensuring all R D activities consistently [...] are prepared for inspections and audits by supporting them in maintaining global regulatory compliance and readiness. Assist in preparing local teams for health authority inspections by providing guidance on best practices and ensuring alignment with global inspection strategies. Additional Qualifications: Expert knowledge of GCP, FDA, EMA, MHRA and ICH requirements. Bachelors degree with 8+ years, Master s degree with 6+ years, [...]
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Job vor 13 Tagen gefunden

Data Analytics Senior Specialist (m/f/x)

• München, Bayern

MEHR

[...] Canada. For Daiichi Sankyo Europe GmbH in Munich we are looking for a qualified Data Analytics Senior Specialist (m/f/x) Purpose of the function: As Systems Manager Senior Specialist in the Database Management and Analytics (DBMA) team within Clinical Safety and Pharmacovigilance (CSPV) , you will focus on data analysis and global adverse event monitoring using Oracle Argus and other data sources. You will act as the subject matter expert for our analytic tools, serving as the primary contact for end users regarding tool usage and training. Additionally, you will [...]

Job vor 14 Tagen gefunden

Director, PV Operations

• Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

[...] a specific focus on highly differentiated products that address unmet medical and consumer needs. By leveraging our unique and enabling R D capabilities, we are building a pipeline that includes inhalable medicines and consumer wellness products. About the role: As Pharmacovigilance Operations Director, you will be reporting to the Head of Safety and working in close links with the safety, regulatory, [...] Lead PV relationships with PV vendor (s) and ensure compliance with relevant Service Level Agreements and Pharmacovigilance Agreements. Provide strategic input to PV- related projects and resourcing decisions to effectively meet safety objectives. Participate in audits/ inspections as Subject Matter Expert (SME) . Foster a culture of excellence, continuous learning, and collaboration. Role Requirements: Advanced life- science degree with minimum 10 [...]
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Job vor 14 Tagen gefunden

Director, PV Operations Basel, Switzerland Full- Time Permanent

• Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

Job vor 14 Tagen gefunden Senior Medical Director Oncology Clinical Development- Solid Tumor • Schaffhausen Führungs-/ Leitungspositionen

MEHR

Job vor 14 Tagen gefunden

Senior Implementation Consultant- RIMS (Remote)

• Frankfurt, Hesse Beratungs-/ Consultingtätigkeiten

MEHR

[...] communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction Influential; experience leading teams through hard decisions and negotiating compromises Technical abilities and willingness to roll up your sleeves to design and implement a RIM solution Expert on life sciences compliance and computer systems validation requirements Ability to work independently in a fast- paced environment Ability to [...] Next Docs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc. Consulting experience, working with a major system integrator or software vendor Regulatory Affairs, Regulatory Operations or Pharmacovigilance background Knowledge of Pharmaceutical, Biotechnology, and/ or Medical Device and Diagnostics regulatory processes, data and content PMP certification Execution experience [...]

Job vor 14 Tagen gefunden Director Regulatory Affairs • München, Bayern Führungs-/ Leitungspositionen

MEHR

[...] HAs and acts as the main point of contact for the local HAs for specific topics/ products under their responsibility. Helps ensure compliance with local law and regulation and consistency with global procedural documents including acting as a subject matter expert or the management of audits and inspections within the affiliate. Provides or contributes to the Vision and Direction for the [...] local requirements and an understanding of current trends in the local affiliate. Must be capable of developing and implementing regulatory strategy and managing complex negotiations with a HA. Knowledge in quality assurance, promotional and non- promotional review as well as pharmacovigilance and market access. People management experience. Experienced leader of projects and teams. Excellent working knowledge regarding country/ national and regional [...]

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Stellenangebote Pharmacovigilance Expert Jobs bei NewScientist Jobs

Job vor 6 Tagen gefunden Bio Marin Pharmaceutical Inc. Associate Medical Director, Clinical Science • London, Greater London, United Kingdom, London (Greater) Führungs-/ Leitungspositionen

MEHR

[...] help build and guide Statistical Analysis Plans (SAPs) Help define study quality metrics and perform study data reviews during study execution to ensure integrity of accruing study data Clinical Science Communication and Collaboration Serve as CLS representative and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed Clinical Study Monitoring Act as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk Initiate and provide [...]

Job vom 27.10.2024 Rx Logix Corporation Content Writer- Pharmacovigilance • London, United Kingdom, London (Greater)

MEHR

Company Overview: Rx Logix is a global leader in pharmacovigilance solutions, providing innovative software and expert consulting services. Our team collaborates with Pharmacovigilance and Risk Management professionals to enhance compliance, productivity, and quality across the drug [...]

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