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Principal Pharmacovigilance Scientist
| Company | Takeda |
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| Location | Cambridge, MA, USA |
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| Salary | $111800 – $191600 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree in Pharmacy, Biology, Biochemistry, Pharmaceutical Sciences, Public Health, or health care related field
- 5 years of Pharmacovigilance (PV) related experience
- Review, analyze, interpret and present complex safety data utilizing data visualization tools to a high standard, with keen attention to detail
- Perform data compilation, identify and evaluate new safety signals and trends by conducting systematic reviews of aggregate data and provide conclusions for aggregate safety documents consistent with global regulatory requirements
- Author aggregate safety reports such as DSUR, PSUR/PBRER, PADER, RMP utilizing guidelines such as ICH, GVP modules V & VII
- Query and generate the safety data reports from the PV safety database (ARGUS) and utilize data visualization dashboards such as Empirica
- Compile strategies for safety data retrieval by utilizing adverse event coding in MedDRA
- Oversee PV safety reporting activities with a thorough understanding of PV regulations (FDA, EMA, Health Canada, GVP, ICH and global regulatory requirements)
Responsibilities
- Facilitate ongoing safety surveillance for assigned products, assisting with data collection and assessment for GST and SMT
- Coordinate and perform signal identification, evaluation and management activities for assigned products
- Assist with authoring safety evaluations, defining scope and methodology, and providing background information for aggregate safety reports
- Assist with conducting preliminary safety analyses and prepare ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses
- Contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs
- Liaise with colleagues in relevant functional areas within and outside of GPSE to gather and provide input for appropriate sections of critical documents (e.g., protocols, ICFs, IBs, etc.)
- Assist with the presentation of patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies (e.g., Takeda Safety Board)
- Build and maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues
- Ensure up-to-date representation of safety information in CCDS (including RSI) and IB, as well as other labelling documents
- Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations
Preferred Qualifications
No preferred qualifications provided.
