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Post: Pharmacovigilance Expert (Drug Safety and Epidemiology)
Job Description:
Provide support to the Brand Safety Leader/Pharmacovigilance Leader (BSL-PVL) in the monitor-ing of the safety profile of assigned products including: Periodic Safety Update Report (PSUR), Risk Management Plan (RMP) updates and associated activities, safety signal detection, coordinat-ing the management of large datasets for analysis purposes , responses to external authorities, review of clinical protocols and other regulatory activities, and responsibility for the clinical review and evaluation of cases including input for follow-up and data cleaning, within agreed timeframes and to a high standard of accuracy, in compliance with IMS business rules, standard operating procedures and global and local regulatory requirements
1. Assist the BSL-PVL in monitoring the safety profile of product
2. Provide input into responses to inquiries from regulatory authorities or health care profes-sionals on safety issues
3. Provide input to responses for CPO requests involving safety issues
4. Assist in the development and updates concerning safety input to the core data sheet and the investigator’s brochure
5. Play an active role in standing and ad hoc Safety Management Team (SMT) meetings
6. Play an active role in SIGDET and MSRB meetings including preparatory activities
7. Assist with project activities on an ad hoc basis
8. Interfaces with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events, updating on PVO requirements
9. Provide clinical input to detailed review of events of interest for key data extraction for analysis purposes including the PSUR and other ad hoc analyses
10. Together with the BSL-PVL, co-author the PSUR including analytical input to PSUR for known and potential risks defined in the RMP
11. Assist in the development and maintenance of the 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
12. Assist in the preparation of other safety documents, as required, including the Annual Safety Update Report (ASR) and the Investigator’s Brochure (IB)
13. Participates in review of clinical study protocols reports other regulatory documents as needed.
14. Provides support as required for licensing activities, regulatory authority inspections audits and for project product recall activities.
15. Lead the training and mentoring of internal and cross-functional team members
Candidate Profile:
Education (minimum desirable): Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD; PhD in relevant field or MD
Languages: Good knowledge fluency in English. Knowledge of other languages desirable.
Experience Professional requirement:
• 4-6 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 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
• Strong organizational and project management skills
• Strong negotiation and communication skills, and the ability to operate effectively in an international environment
• Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process
• Strong technical and problem solving skills
• Good presentation skills
• Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases applications.
• Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.
• Ability to mentor, and coach within IMS and cross functionally
• Ability to lead global work groups
• Ability to lead and deliver initiatives
Additional Information:
Experience: 4-6 years
Location: Hyderabad
Education: BS, Pharm.D, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 77712BR
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