Drug Safety Physician

Kelly Services
  • Chandigarh
  • 10-15 lakh
  • 1-5 years
  • 19 Mar 2015

  • R&D/ Research & Development, Medical Services

  • Hospitals/ Health Care
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

UG: MBBS - Medicine

PG:Post Graduation Not Required, M.S/M.D - Any Specialization

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

we need MBBS/MD physicians who can commit to work for at least 2 years and they should preferably be from North India.

Competencies/Skill sets for this job

Safety Drug Safety Medical Review Medical Medicine

Job Posted By

About Organisation

Kelly Services