Position
: Senior Drug Safety Physician

Location
: Chandigarh

Work Experience:
Minimum 2-3 years of experience in Pharmacovigilance

Job Overview

Performing medical review of Individual Case Safety Reports (ICSRs); preparation of aggregate reports; performing activities related to signal management for client pharmaceutical products,

medical review of narratives for Clinical Study Reports (CSRs), according to client guidelines and

Standard Operating Procedures (SOPs) and applicable regulatory requirements

Functional Responsibilities

Responsible for any or all of the following activities, including but not limited to:

• Contributing (authoring and/or medical review) to aggregate reports like Periodic Safety

Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs),

Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO),

Internal Periodic Safety Review (IPSR), Risk Management Plans (RMPs)] or other

scheduled or unscheduled reports, as required

• Medical review of ICSRs for marketed and investigational human and veterinary products,





ensuring accurate capture of safety data within patient narratives and critical data fields

which impact medical evaluation (i.e. seriousness, causality, expectedness assessment,

MedDRA coding)

• Providing medical advice to PV Scientists to assist them with processing of ICSRs

• Drafting Analysis of Similar Events (AOSE) summary for Reliable Unexpected Suspected

Adverse Reactions (SUSARs)

• Signal Management activities including Signal Detection, Validation, Prioritization,

Analysis & Assessment

• Review of published literature articles/abstracts

• Review of case listings including review of serious unexpected associated listings, listings

of special situations like mortality, paediatric, elderly, pregnancy, lack of effect, etc.

• Medical Review of safety narratives for Clinical Study Reports (CSRs)

• Performing additional drug safety related activities, as assigned

• Interac

📌 Senior Drug Safety Physician (Chandigarh)
🏢 CONTINUUM India
📍 Chandigarh