14/10 Subhashree Pattashani
HR at Symbiance

Views:138 Applications:2 Rec. Actions:Recruiter Actions:2

Medical Reviewer/Drug safety Physician - Hospital - MD (10-15 yrs)

Chennai Job Code: 7866

Medical reviewer- Global Safety and Pharmacovigilance:

- Responsible for the timely Medical Evaluation of the individual case reports on a daily basis

- Perform medical coding for each ICSR in accordance with Guidelines and SOPs using Medical Dictionary for Regulatory Activities (MedDRA); confirm the accuracy of terminology and coding and manually recode any errors or inconsistencies as needed per Guidelines and SOPs

- Responsible to perform the medical and regulatory evaluation of all Individual Case Safety reports (ICSRs) for assigned cases

- Review, evaluate and identify need to follow up of ICSRs; identify reportable cases; create case series for analysis of similar events

- Accountable for medical evaluation/interpretation of aggregate safety data of products assigned including signal detection and evaluation, regulatory safety reports and ad hoc safety review/assessments

- Conduct the seriousness assessment and global expectedness assessment

- Guide the drug safety associates in generating adverse event queries, liaising with the ICSRs manual/Client to agree upon the queries, and send request for additional information to reporter

- Participate in audits/inspections as required/appropriate

- Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects

- Mentor or train associate Pharmacovigilance Physicians/drug safety team on Medical Review processes

- Resolving medical queries with respective ICSR/product safety to safety data associate, local safety officers, medical doctors/health care professionals and consumers

Skills: Must possess strong medical evaluation and judgement of causality between AE and the drug

- Must have a good understanding of the project requirements and must possess strong problem-solving and leadership skills

Education: Qualified Physician with MBBS/MD Degree with certification

- Minimum of 10 years of experience in pharmaceutical industry, Pharmacovigilance processes and procedures

- Benefit-risk related strategy experience required

- Ability to mentor, and coach within team and cross functionally

- The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills

- Excellent knowledge of regulatory requirements

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