Full-Time Senior PV Physician I

• 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

• Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment.
• Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance.
• Review and approve literature screening search strategy.
• Cooperate in the preparation of and provide input in Risk Management Plans
• Review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, ACOs or Annual Safety Reports.
• Actively participate in the Drug Safety Review Committee - signal detection and risk evaluation process for Client company medicinal products in the product's life cycle.
• Provide training and mentoring of junior PV Physicians

• Medically qualified as a physician
• Previous experience in pharmacovigilance
• Ability to review different aggregate report types including PBRERs and DSURs
• Expertise in signal detection activities is essential
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• English - advanced (spoken, written)

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