Physician - Drug Safety (mbbs/md)

Kelly Services
  • Chandigarh
  • Confidential
  • 1-5 years
  • 193 Views
  • 21 Sep 2015
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  • Medical Services

  • Hospitals/ Health Care
Job Description

Prefer MD in Pharmacology / Microbiology / Biochemistry


Note: The Clients general inclination is towards the physicians who do not have PV Experience so that Client can train them per our requirements.

Education:
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