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CONTINUUM employs scientists and physicians for performing activities in the domains of Pharmacovigilance, Regulatory, Evidence Evaluation and Technology. Please write to us at [email protected] and we would reach out to you, if your resume is found to be suitable

Drug Safety Physician - Position Code: DSP001

Location: Chandigarh

Report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)] from aggregate data for products, in accordance with client conventions and requirements; Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Signal Evaluation Reports/ Drug Safety Reports , review of published literature and case listings; Vigilance over significant/designated medical events; Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans (RMPs); Follow-up and interaction with clients to obtain incomplete/missing information,



with a view to resolving and clarifying issues; Performing medical review of individual case safety reports (ICSRs); Performing medical review of narratives for Clinical Study Reports (CSRs); Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives; Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs); Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions; Maintaining records in compliance with guidelines and SOPs.

Minimum qualification(s):
A degree in Medicine (MBBS) or a post-graduation qualification (MD), preferably in a clinical branch; Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text; Ability to evaluate and interpret data, draw conclusions independently and synthesize scientific data; Fluency in written and spoken English; Proficiency in computer skills in Windows 10/ Windows 7 Operating system and the MS office suite (Word/Excel/Powerpoint) and an ability to work with web-based applications; Typing and transcription accuracy; Attention to detail.

Note::
Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position.

📌 Drug Safety Physician (Chandigarh)
🏢 Continuum India
📍 Chandigarh