Medical Reviewer-Clinical Trials-Assistant Manager-Pharmacovigilance
- Posted On: 2026-04-30 17:29:53
- Openings: 10
- Applicants: 0
Job Description
Role & responsibilities
1. Engage in cross-functional safety review of Individual Case Safety Reports (ICSRs) for both products under clinical development and those already on the market & review of clinical trial safety data.
2. Review and contribute to the safety components of study-related documents, including study protocols, Investigator's Brochure (IB), Informed Consent Form (ICF), Case Report Forms (CRFs), Serious Adverse Event (SAE) forms, Suspected Unexpected Serious Adverse Events (SUSARs), Treatment Emergent Adverse Events (TEAE), clinical study reports, and Safety Management Plans (SMP).
3. Author/review all types of safety reports including DSURs, PSURs, PBRERs, Addendum to Clinical Overview, other Benefit-Risk/Safety Assessment reports and Analysis of Similar Events (AoSE).
4. Perform signal detection and evaluation.
5. Assist in the evaluation and execution of regulatory intelligence initiatives.
6. Offer technical expertise in the creation and maintenance of procedural documentation.
Facilitate audits, inspections, and Corrective and Preventive Action (CAPA) management
Preferred candidate profile
Educational Qualification : MBBS /MCI Registration in India
Experience : 2 to 5 Years in Pharmacovigilance
Experience in Medical review of ICSR Cases(Pre-marketing)
More Info
Education
Required Skills
Contact Details
Latest Job
Similar Jobs
- 3 years
- Mumbai
- 4 Days
- Fresher
- Mumbai
- 4 Days
- 2 years
- Mumbai
- 4 Days
- 6+ years
- Mumbai
- 4 Days
- 4 years
- Mumbai
- 4 Days
- 6+ years
- Mumbai
- 4 Days