Medical Reviewer-Clinical Trials-Assistant Manager-Pharmacovigilance

Glenmark Pharmaceuticals

Posted: 4 months ago
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)