MBBS Freshers - MNC CRO/ Chandigarh/ Drug Safety Physician
Kelly Services India Pvt. Ltd. hiring for Kelly's Client
1 - 6 yrs
Chandigarh
Job Description
- Dear Candidate,
Greetings from Kelly Services!!!
We have an urgent position for MNC- CRO at Chandigarh.
Designation- Drug Safety Physician
In broad terms, we need MBBS / MD physicians.
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:
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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