Full-Time Senior PV Physician I

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

Qualified Person Support: Act as a Qualified Person for Pharmacovigilance or support the Qualified Person in medical understanding and evaluation of safety issues.

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

Literature Review: Review articles to identify ICSRs/SAEs related to the medicinal product or other safety findings.

Risk Management Plans: Cooperate in the preparation of Risk Management Plans and provide input.

Regulatory Authority Requests: Support preparation of responses to regulatory authority requests.

Signal Detection: Review line listings, participate in signal detection activities (meetings, reports), and consult clients on benefit/risk assessment and risk minimization.

Signal Evaluation: Evaluate and categorize possible signals, propose a course of action.

Benefit-Risk Reports: Support preparation and review of benefit-risk reports.

Medical Qualification: PV Physician must be medically qualified as a physician.

Pharmacovigilance Experience: Previous experience in pharmacovigilance is required.

Report Review Expertise: Ability to review different aggregate report types (PBRERs, DSURs).

Signal Detection Expertise: Expertise in signal detection activities is essential.

Interpersonal Skills: Excellent interpersonal skills.

Time Management: Ability to plan, organize, prioritize, and execute multiple tasks.

Cross-Cultural Teamwork: Ability to work effectively cross-culturally and cross-functionally, valuing teamwork.

Communication and Presentation Skills: Strong communication and presentation skills.

English Proficiency: Advanced English (spoken and written).

Computer Skills: Advanced literacy in MS Office.

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