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Sr Pharmacovigilance Expert

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Provide support for medical safety management within the IMS Department, including single case medical review and related activities, aggregate reports including coordination and management of large datasets for analysis purposes, and preparation of responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global and local regulatory requirements. Performs signal detection for assigned products in the Empirica Signal tool. Provide input to medical safety aspect for dedicated projects, lead internal management teams such as SPT or SMT.1.Performs medical review of single cases from all sources, including review of events associated to quality defects 2. Manages or supports the preparation and review of Investigator Notifications (INs) and distributes INs3. Performs signal detection and signal evaluation activities for assigned products, and SMART topic updates 4. Authors or co-authors the medical sections of periodic reports (PBRER, DSURs per project assignment), assists in or leads the preparation of other safety related documents, including Investigator Brochures (IB), Core Data Sheets (CDS), Product Guidance Documents (PGD), Expert Statements, and Responses to Health Authorities inquiries5. With BSL/PVL s support, assists in the development, maintenance and implementation of RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures. The Sr. PVE will assume increasingly independent ownership of these processes6. Regularly and independently contributes to the evaluation and writing of the medical sections of other study deliverables including, but not limited to, clinical overviews, ad hoc Health Authority queries, Drug Safety Product Profile (DSPP), and Drug Safety Update Report (DSUR) 7. Regularly interfaces with the clinical team for safety matters, including follow-up on events of interest, input into site queries regarding adverse events, and updating Team on PVO requirements8. For tasks assigned by BSL/PVL, acts as the main IMS contact at internal management teams as SPT, SMT, GPT, and for licensing collaborations 9. Supports preparation for and participates on internal safety reviews boards, such as SMT, MSRB, and SIGDET10. Provides support to BLS/PVL for quality assurance activities, internal audits, and Health Authority inspections 11. Acts as Deputy for product specific PVLs, assuming full responsibility during the deputation period12. Lead the training and mentoring of newly recruited colleagues by supporting their integration into the PVE role. Note While the majority of the responsibilities are the same as for PVEs, the primary considerations for Sr. PVE include the seniority, relevant experience and ability to perform major tasks defined in Job Description consistently and independently, with minimal supervision. 13. Quality of work delivered (attention to details, thoroughness, medical sound judgment, and medical writing skills)14. Writing concise, accurate and quality documents 15. Timeliness of deliverables according to established directives16. Compliance with Internal and external regulations and procedures 17. High level of independence18. Effective communication with- and support to- product safety Colleagues and project functions.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 3-6


Clinical Research | Data Management/ Statistics | Documentation/ Medical Writing | Research Scientist
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