Drug Safety Physician

by Quantum Solutions India in Chandigarh

Experience: 0 to 3 yrs.Posted on: 20 Feb

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Job Description

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Report preparation [e.g. Periodic Safety Update Reports (PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US 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, 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; 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.

Salary:

Best in the industry

Industry:

Pharma / Biotech / Clinical Research

Farea:

Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:

Drug Regulatory Affairs/Documentation

Role:

Documentation/Medical Writing

Keyskills:

PhysicianMBBS MD Medicine Doctor Medical WriDrug Safety CRO Pharmacovigilance

Desired Candidate Profile

Education:

UG - MBBS - Medicine
PG - Post Graduation Not Required, Any Postgraduate - Any Specialization, M.S/M.D - Any Specialization
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required

A degree in Medicine (MBBS) or a post-graduation qualification (MD), preferably in a clinical branch; Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position; 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 MS XP/Vista/Windows 7 Operating system and the MS office suite (2003/2007/2010 & Word/Excel/Power point) and an ability to work with web-based applications; Typing and transcription accuracy; Attention to detail

Company Profile

Quantum Solutions India
https://www.qsi.in

A Chandigarh-based firm servicing the Pharmaceutical/ Healthcare/ Medical industries. The firm specialises in pharmacovigilance work for overseas clients.

Contact Details

Contact Company:

Quantum Solutions

Email Address:

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