We are seeking an experienced Clinical Safety Physician-|| to support and oversee clinical safety and pharmacovigilance activities across global clinical development programs. The role involves medical safety review, signal detection and management, aggregate reporting, literature review, risk management, and support for regulatory and Health Authority activities. The successful candidate will collaborate closely with Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Clinical Operations, CROs, and other cross-functional stakeholders to ensure high-quality and compliant safety deliverables.

ROLE DETAILS

Location: PAN India

Experience: 8–12 Years

Domain: Life Sciences / Bio-Pharma

Role: Clinical Safety Physician-||

EDUCATION

MBBS and/or MD.

KEY RESPONSIBILITIES

• Conduct literature reviews for ICSR, new safety signals, and aggregate reports.

• Author and review safety sections of SSSRs, DSUR, aCO & PBRER.

• Provide MAH comments for literature and safety sections.

• Contribute to RMP updates and implementation plans.

• Review and assess safety information related to important safety concerns.

• Perform signal detection, validation, assessment, and management.

• Conduct DSR authoring, single-case analysis, MAH comments, and overall conclusions.

• Develop and apply appropriate strategies and methodologies for signal assessment.

• Review safety content for medical, scientific, and regulatory accuracy.





• Review Clinical Study Report (CSR) safety sections and narratives.

• Provide medical expertise and support for Health Authority requests.

• Lead or contribute to process improvement, technology, and innovation initiatives.

• Participate in internal and external audits and inspections.

• Provide mentorship, oversight, and training to less experienced colleagues.

• Lead and participate in internal and external stakeholder meetings.

• Collaborate effectively with cross-functional safety teams.

REQUIRED SKILLS

• Solid experience in Clinical Safety / Pharmacovigilance

• Expertise in Signal Management and Aggregate Reporting

• Strong knowledge of relevant regulatory and scientific guidelines

• Experience with literature review and safety assessment

• Knowledge of ICSR, DSR, DSUR, PBRER, SSSR and RMP processes

• Strong medical and scientific review capabilities

• Experience supporting Health Authority requests

• Excellent stakeholder management and communication skills

• Ability to independently manage safety activities and deliverables

• Strong leadership, mentoring, and cross-functional collaboration skills

PREFERRED EXPERIENCE

Professionals with experience managing clinical safety activities, signal management, aggregate reports, medical review, and cross-functional safety programs are preferred.

INTERESTED CANDIDATES CAN SHARE THEIR UPDATED CVs AT:

[email protected]

📌 Drug Safety Manager (Mumbai)
🏢 Latinum Hr Solutions
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