Full-Time Senior Pharmacovigilance Physician I

Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports in clinical trials for medical/causality assessment, including coding, seriousness assessment, Company causality and comment, listedness/expectedness, and follow-up questions.

Act as a Qualified Person for Pharmacovigilance or support the Qualified Person (if not medically qualified) in medical understanding and evaluation of safety issues.

Review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, and literature screening search strategy.

Review articles to identify ICSRs/SAEs related to the relevant Medicinal Product or other safety findings.

Cooperate in preparing and providing input in Risk Management Plans.

Support the preparation of responses to regulatory authority requests.

Signalling:

• Reviewing line listings
• Participating in signal detection activities (meetings, writing reports, and consulting on benefit/risk assessment and risk minimization)
• Evaluating and categorizing potential signals and proposing courses of action
• Supporting preparation and review of benefit-risk reports

Essential skills and experience:

• Medically qualified physician
• Previous pharmacovigilance experience
• Ability to review diverse aggregate report types (PBRERs, DSURs)
• Expertise in signal detection
• Strong interpersonal skills
• Excellent planning, organization, prioritization, and execution skills
• Cross-cultural and cross-functional collaboration skills
• Excellent communication and presentation skills
• Advanced English (spoken and written)
• Advanced MS Office skills

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