- Takeda Pharmaceuticals (Boston, MA)
- …the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** :Medical Director Pharmacovigilance , Rare Disease & PDT **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance , Rare Disease & PDT with...safety expert for assigned pharmaceutical / biological / drug device combined products, accountable for the safety… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with cross-functional stakeholders, including R&D Quality Business Partners (QBPs), Patient Safety , and QPPV. The Director will work with stakeholders ... to proactively identify, evaluate, and mitigate pharmacovigilance compliance risks. In addition, the Director ...Quality Auditor is preferred. + Expert knowledge of the drug development process and GVP, including global regulations (FDA,… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical ... of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug ....depending on the program / portfolio being led. The Director , Safety Scientist provides key support as… more
- Pfizer (New York, NY)
- …the team including regular communications, coaching, and mentoring of the team as required. ** Director Safety Risk Lead (MD Role):** + Makes decisions based on ... medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or drug development. + Disease area-specific knowledge:… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …in PV and/or relevant medical field or equivalent in lieu industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in ... Safety Organization is looking for a Senior Director (Obesity) to join our organization! **In this role,...the therapeutic area of interest. + Thorough understanding of drug development and context as applicable to safety… more
- Ascendis Pharma (Princeton, NJ)
- …8 years recent experience in Pharmacovigilance + Working knowledge of validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and ... + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements...health care field with relevant pharmaceutical industry experience in drug safety . + Candidates with advanced scientific… more
- Amgen (Washington, DC)
- …lives of patients while transforming your career. **Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote** **What you will do** ... input to protocols, statistical analysis plans, and clinical study reports + Prepare/review safety sections of new drug applications and other regulatory filings… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in people management. + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... **Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee… more
- Lilly (Indianapolis, IN)
- …thinking, and decision-making skills. + Proven track record of successfully managing drug safety operations in a biotechnology or pharmaceutical company. + ... accountability for managing key ICSR vendor relationships. In addition, the Sr. Director leads global projects involving complex safety systems, ensuring… more
- Lilly (Indianapolis, IN)
- …industry experience and clinical trial experience, or experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance , ... industry experience and clinical trial experience, or experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance ,… more
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