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: [email protected] & [email protected]

📌 SERM Scientist (Bengaluru)
🏢 Latinum Hr Solutions
📍 Bengaluru