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Post : Sr Pharmacovigilance Expert
Job Description
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 INs
3. 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 inquiries
5. 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 processes
6. 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 requirements
8. 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 SIGDET
10. 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 period
12. 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.
Candidate Profile
Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical Degree (MBBS or MD) Good knowledge/fluency in English. Knowledge of other languages desirable.
• 3-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral
• Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
• Excellent understanding of clinical trial methodology, GCP and medical terminology
• Attention to detail and quality focused
• Ability to operate effectively in an international environment
• Excellent understanding of physiology, pharmacology, and the drug development process including its interactions with HAs
• Strong technical and problem solving skills
• Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.
Additional Information :
Experience : 3-6 years
Qualification : B.Sc. / B.Pharm Nursing / Pharm.D / or MBBS or MD
Location : Hyderabad
Industry Type : Pharma
Functional Area : Market Access
End Date : 25th, May, 2018
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