Full-Time Medical Director (Pharmacovigilance)
Ergomed is hiring a remote Full-Time Medical Director (Pharmacovigilance). The career level for this job opening is Manager and is accepting Warsaw, Poland based applicants remotely. Read complete job description before applying.
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Ergomed
Job Title
Medical Director (Pharmacovigilance)
Posted
Career Level
Full-Time
Career Level
Manager
Locations Accepted
Warsaw, Poland
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Job Details
The Medical Director will lead and develop the PV physician team, ensuring competence in pharmacovigilance.
Responsibilities:
- Assign PV physicians to client projects ensuring quality and compliance.
- Act as a point of contact for client issues, maintaining relationships.
- Present and discuss safety data at client meetings.
- Integrate and analyze safety information from preclinical through post-marketing stages.
- Provide safety input to clinical development programs.
- Review Investigator’s Brochures, Clinical Study Protocols, and Study Safety Plans.
- Draft responses to drug safety matters from Competent Authorities.
- Involve in Risk Management Plans and other aggregate reports.
- Participate in Drug Safety Review Committee for signal detection and risk evaluation.
- Provide high-level consultancy on medical aspects of pharmacovigilance.
Company Responsibilities:
- Oversee and manage pharmacovigilance physicians, ensuring quality and timeliness.
- Work cross-functionally to provide guidance on medical safety collaborations.
- Support quality and efficiency strategies.
- Oversee key performance indicators.
- Support risk-based assessments and mitigation plans.
- Ensure escalation of potential quality issues.
- Support the Business/Commercial team in contract development.
- Attend bid defense meetings and conferences as a medical expert.
- Deliver PV medical training.
- Develop and update medical SOPs.
- Maintain awareness of developments in pharmacovigilance and pharmacoepidemiology.
- Act as EEA QPPV and/or Deputy.
Requirements:
- Medically qualified physician with relevant postgraduate qualification.
- Minimum of 15 years of experience in clinical research and pharmacovigilance.
- Experience in proactive safety profile monitoring and signal detection.
- Experience reviewing aggregate report types.
- Experience as a Qualified person for pharmacovigilance.
- Experience in business development activities and bid defense meetings.
- Experience authoring/reviewing PV procedures.
- Experience managing multiple strategy formulations.
- Comprehensive knowledge of global Pharmacovigilance regulations.
- Leadership and managerial experience.
Skills
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Medical Director (Pharmacovigilance) at Ergomed is
18th of September 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Warsaw, Poland
] applicants. .
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