Full-Time Medical Reviewer II

Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes 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 for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues.

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

Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings.

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

Supporting the preparation of responses to regulatory authority requests.

Signalling:

• Reviewing line listings
• Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
• Evaluating and categorizing possible signals and proposing a course of action
• Supporting preparation and review of benefit-risk reports

Essential Skills:

• Previous experience in pharmacovigilance
• Ability to review different aggregate report types including PBRERs and DSURs
• Expertise in signal detection activities
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross-culturally and cross-functionally
• Value the importance of teamwork
• Communication skills
• Presentation skills
• English - advanced (spoken, written)
• Advanced literacy (MS Office)

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