Associate Director International PV
New
B
BiomapasPharmacovigilance
Role is open for candidates in any EU country.Full-TimeDirector
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 6 years of work experience in PV functions and 1 year of experience in managing PV teams
- Required Skills
- Project ManagementPeople Management
Requirements
- Life science degree such as Biologist, Pharmacist, or Medical Doctor.
- Minimum of 6 years of work experience in Pharmacovigilance functions.
- At least 1 year of experience in managing Pharmacovigilance teams.
- Expert knowledge of international regulations including ICH, EU GVP Modules, UK guidelines, and FDA.
- Demonstrated experience in PV medical writing.
- Strong project management skills.
- Ability to evaluate, interpret, and present safety data.
- Proven ability to implement PV strategies and develop systems.
- Professional level proficiency in English, both oral and written.
- Strong leadership, collaboration, decision-making, and problem-solving skills.
Responsibilities
- Manage full Pharmacovigilance systems and projects to ensure compliance and quality.
- Execute QPPV Office strategy and drive process harmonization across regions.
- Oversee department forecasting, budget planning, and support RFI/RFP documentation.
- Maintain the Pharmacovigilance System Master File (PSMF) and related governance documentation.
- Supervise core PV deliverables including PSURs, RMPs, literature monitoring, and signal management.
- Ensure oversight of partner safety data exchange agreements and audit/inspection readiness.
- Monitor regulatory changes and act as a subject matter expert for PV processes.
- Manage assigned regional QPPV teams, including goal setting and resource allocation.
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