SERM Scientist

SERM Scientist

Role : Safety Evaluation and Risk Management (SERM Scientist)

Experience: 3+ Years

Locations: Mumbai/Pune/Bangalore/Noida

Budget: Up to 30 LPA

Qualification: B.Pharm | M.Pharm | Pharm.D | Life Sciences | Biomedical Sciences

ROLE RESPONSIBILITIES :

• Perform signal detection, validation, evaluation, and safety assessment for assigned pharmaceutical products.
• Conduct detailed safety evaluations and risk assessments, identifying emerging safety concerns and providing scientifically sound conclusions.
• Author and review aggregate safety reports, including PSUR, PBRER, and DSUR.
• Support the preparation and maintenance of Risk Management Plans (RMPs) and related safety documentation.
• Identify, assess, document, and escalate potential safety signals and emerging safety issues.
• Recommend appropriate risk minimization and risk mitigation measures based on safety assessments.
• Provide scientific input into clinical development and post-marketing safety activities.
• Support Health Authority responses, regulatory submissions, audits, and inspection readiness.
• Collaborate with Pharmacovigilance, Clinical, Regulatory Affairs, Medical, Epidemiology, and other cross-functional teams.
• Ensure compliance with ICH, GVP, CIOMS, and applicable global PV regulations.

MUST-HAVE EXPERIENCE:

• Signal Detection & Signal Evaluation
• Authoring and Reviewing Aggregate Safety Reports
• PSUR / PBRER / DSUR
• Safety & Risk Assessment
• Risk Management / RMP
• ICH / GVP / CIOMS
• Pharmacovigilance / Drug Safety

Interested candidates can share their updated resume at: [HIDDEN TEXT] & [HIDDEN TEXT]