Hiring for Drug Safety Physician (Md Pharmacology/bio Chemistry/physiology/mbb), in Chandigarh, Mohali for Exp. 0 - 5 yrs at Kelly Services India Pvt. Ltd..

  • Esteemed client of Orion TrueTech Services India
  • Chandigarh, Punjab, India
  • Sep 13, 2017
Full time Pharma, Healthcare & Biotechnology Jobs

Job Description

Job Description:In broad terms, we need MBBS &amp amp nbsp / MD physicians . Prefer MD in Pharmacology / Microbiology / Biochemistry/Physiology/ Community Medicine&amp amp nbsp 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