Full-Time PV Physician II

• Responsible for medical review of ICSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS, PBRERs, PADERS).
• Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment.
• Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required.
• Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues.
• Review and provide input in periodic reports.
• Review literature screening search strategy and articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings.
• Support signal detection activities upon acquiring sufficient experience.
• Propose a course of action whenever a new risk is identified.

Requirements:

• Medically qualified as a physician with demonstrated experience in PharmacoVigilance and working in a clinical setting.
• Excellent interpersonal, communication and presentation skills.
• Ability to plan, organise, prioritise and execute multiple tasks.
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork.

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