POS 4035
Status 10

Global Head of Pharmacovigilance

Beschreibung: For one of our German Biotech clients we are seeking freelance support as: Global Head of Pharmacovigilance (M/F/D)
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  • Set up and implement strategy for the global pharmacovigilance and safety operations for a portfolio of products/programs, ensuring the development of safety processes, tools and system implementation
  • Strategically develop and implement post-marketing pharmacovigilance processes and contribute to the product specific Risk Management Plan
  • Represent the company on co-development teams for assigned products/programs and liaison with co-development partners to ensure coordinated safety reporting activities
  • Provide guidance to product/program teams and CROs for safety case review and adjudication
  • Participate in the review and interpretation of clinical trial results, particularly for understanding and interpretation of product safety
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  • Start: asap // Duration: 6 months + // Capacity: 5 days/week
  • Medical Doctor or PhD in Nursing, Public Health of Pharmacy
  • +10 years of experience in pharmacovigilance, product safety and/or clinical operations within the biotech, CRO or pharmaceutical industry
  • Profound (Pre-) launch experience
  • Experience in designing or implementing safety reporting/safety management processes, systems and tools to support both case-level review and trend analyses
  • Ability to implement product and study-level risk assessment and risk mitigation into global drug development
  • Knowledge and experience in signal detection methodologies
  • Experience in managing teams responsible for safety operations and/or pharmacovigilance is required; readiness to take over QPPV responsibilities
  • Expert knowledge of global safety reporting regulations, including US and EU requirements
  • Knowledge in Regulatory audits and inspections, as well as management of partners and vendors
  • Working experience from small and large companies
  • Nice to have: Knowledge of Vaccines/ Infectious Diseases
  • Must Have: Business fluency in English
  • Nice to have: German
Bemerkungen: WANTED: Head of PV (M/F/D). Please contact +49 89 18 90 998 26 or Skills: CRO Experience, English, German, Infectious Diseases and Venereology, Medical Doctor / Physician, Pharma, PV Systems (Pharmacovigilance), QPPV (Qualified Person Pharmacovigilance), Vaccines
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 6 months +
Einsatzort: Germany
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