Drug Safety Physician

Kelly Services India Pvt. Ltd.
  • Chandigarh, Mohali
  • 9-12 lakh
  • 0-5 years
  • Views
  • 09 Jan 2018

  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

In broad terms, we need MD Pharmacology / MD Community Medicine / MBBS Prefer MD in Pharmacology / Microbiology / Biochemistry/Physiology/ Community Medicine Also MBBS having 2+ Years of experience can apply for this Position) Education: UG: MBBS - Medicine PG:Post Graduation Not Required, M.S/M.D - Any Specialization MD Pharmacology preferred Doctorate: Doctorate Not Required **Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position; A degree in Medicine (MBBS) or a post-graduation qualification (MD) is desired . Fluency in written and spoken English is must Job Description 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

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Kelly Services India Pvt. Ltd.