Full-Time Senior Pharmacovigilance Physician I

The Senior Pharmacovigilance (PV) Physician I is responsible for: medical review of ICSRs, writing and/or reviewing signal detection reports, writing and/or reviewing aggregate reports (DSURS, PSURS, PBRERs, PADERS), reviewing risk management reports (RMPs) and mentoring junior PV Physicians.

The Senior PV Physician I also supports the QPPV in medical aspects and safety issues as needed by Company or Client.

For the Client:

• Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment.
• Complete the adverse event tracker for all ICSRs reports.
• Act as a Qualified Person for Pharmacovigilance or support the Qualified Person in medical understanding and evaluation of any safety issues.
• Review and approve literature screening search strategy and articles for ICSRs/SAEs.
• Cooperate in the preparation of and provide input in Risk Management Plans.
• Supporting/leading the preparation of responses to regulatory authority requests.
• Review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, and Annual Safety Reports.
• Act as Company Lead in a specific pharmacovigilance area requiring medical input (e.g., preparation of reference safety information).
• Actively participate in the Drug Safety Review Committee.

Signalling:

• Participate in signal detection activities, meetings, and provide consultation on benefit/risk assessment and risk minimisation.
• Evaluate and categorize possible signals.
• Propose a course of action for possible signals.
• Support preparation and review of benefit-risk reports.
• Support PV Project Managers in planning and preparation.
• Oversee the quality of signal detection activities.

For the Company:

• Support the preparation of PV procedures.
• Provide training and mentoring of junior PV Physicians.
• Provide medical advice to project teams.
• Continuously work on the development of company-level procedures.
• Support the Director of Projects and QPPV as needed.
• Support the Medical Director in training and mentoring.

Required Skills and Experience:

• Medically qualified as a physician.
• Previous pharmacovigilance experience.
• Ability to review different aggregate report types.
• Expertise in signal detection activities.
• Excellent interpersonal and communication skills.
• Advanced English (spoken and written).
• Advanced MS Office literacy.

What is the last date for applying to the job?

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