Principal Pharmacovigilance Scientist

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Principal Pharmacovigilance Scientist

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Principal Pharmacovigilance Scientist with the following duties: 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. 10% domestic travel required. 100% telecommuting allowed from anywhere in the U.S.

REQUIREMENTS: Bachelor’s degree in Pharmacy, Biology, Biochemistry, Pharmaceutical Sciences, Public Health, or health care related field plus 5 years of Pharmacovigilance (PV) related experience. Prior experience must include: 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 (Development Safety Update Report), PSUR (Periodic Safety Update Report)/PBRER (Periodic Benefit-Risk Evaluation Report), PADER (Periodic Adverse Drug Experience Report), RMP (Risk Management Plan) etc., utilizing guidelines such as ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), GVP (Good Pharmacovigilance Practice) 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 [Food and Drug Administration], EMA [European Medicines Agency], Health Canada, GVP [Guideline on Good Pharmacovigilance Practices modules], ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] and global regulatory requirements.

Full time. $111,800 - $191,600 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0150652. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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