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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. > |
Drug Safety Physician(md,mbbs) |
Designation / Job Role | : | Other | |
Job Description | : |
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. |
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Speciality | : | Other | |
Number of Openings | : | 1 | |
Hiring For | : | Client Of Kelly services | |
Location(s) | : | Chandigarh | |
Country | : | India | |
Experience | : | 0 - 5 year(s) | |
Salary | : | Not Specified | |
Salary Remarks | : | Not Disclosed by Recruiter | |
Date Posted | : | 31-Dec-2014 | |
Application Deadline | : | Not Specified | |
Requirements |
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Education | : | MBBS- Medicine M.S/M.D - Any Specialization Any Doctorate - Any Specialization, Doctorate Not Required | |
Candidate Profile | : | Please refer to the Job description above | |
Company Profile |
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Posted By | : | Mr. DocLynk Admin | |
Organisation Name | : | Medigrity | |
Designation | : | Administration | |
Job Reference | : | Not Specified | |