Job Description

Hi,

We are hiring for one of India's leading IT & consulting organizations for the position of Clinical Safety Physician Role.

Summary

A Clinical Safety Physician is a medical doctor in the pharmaceutical industry who monitors, evaluates, and manages the safety profile of drugs during development (clinical trials) and after they are marketed. They review adverse events, ensure regulatory compliance, and assess benefit-risk profiles to ensure patient safety

Key Skills

• Minimum 7 years experience in Literature Review & ICSR Assessment with evaluation of case validity, causality, and clinical relevance for safety reporting
• Safety Signal Detection & Evaluation using multiple data sources with medical judgment and risk assessment approach
• Aggregate Report Preparation (PSUR/PBRER/DSUR) including data analysis, safety evaluation, and regulatory-compliant documentation
• Drug Safety Report (DSR) Authoring & Review covering single case analysis, signal assessment, and overall medical conclusions
• MBBS and/ or MD

Key Responsibilities

• Provide mentorship, oversight and training of less experienced colleagues.
• Have a good understanding of all in scope processes.
• Contribute to all signal management activities with medical expertise, i.e. contribute to detection, validation, DSR strategy and SME review, from time-to-time author parts of DSRs (e.g. conclusion).
• Confidently participate in report kick-off meetings and other meetings, as necessary.
• Review of Clinical Study Reports (CSRs) safety sections and narratives for CSRs or health authority requests.
• Provide expert medical input to aggregate reports and other processes.
• Support Health Authority requests with medical expertize, including review and authoring of critical parts as/if necessary.
• Lead or contribute to process improvement and technology / innovation activities.
• Participate in internal and external audits and inspections, as required.
• Take proactive ownership of delegated molecule safety activities, contributing to ensuring patient safety and the molecules safety strategy, i.e. proactive suggestions for SRP, DSR strategy, addressing SRR topics.
• Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action) /deliverables.
• Consistently delivering quality the first time across processes.
• Showing a thorough understanding and competency how the different pharmacovigilance processes connect.
• Excellent collaboration and leadership to cross-functional safety teams.
• Independence, ownership and high competence in the conduct of all Clinical safety science responsibilities.
• Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e.g., 5.2.4, 6.2, 9.2, 15 & 16).
• Authoring of RMP updates & implementation plans.
• Review of various types of listings for Signal Detection.
• DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review

More Info

Education