Drug Safety Physician

Job Description

Work With Us! A leading contract research organization trusted by leaders CONTINUUM employs scientists and physicians for performing activities in the domains of Pharmacovigilance, Regulatory, Evidence Evaluation and Technology. Please write to us at careers@continuumindia.com 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 important/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.