- 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
- Lilly (Indianapolis, IN)
- …health science or information technology) + 2+ years of experience supporting drug development areas (eg, Safety , Clinical, Project Management, Tech@Lilly, ... life better for people around the world. The purpose of the Associate Director PV Systems Strategy and Implementation is to develop, implement, and maintain… 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
- 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
- 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)
- …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
- ThermoFisher Scientific (Greenville, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance medical monitoring (comparable to 2 years). + For Medical ... (comparable to 2+ years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2+ years) + Preferences are towards individuals with… more
- ThermoFisher Scientific (Greenville, NC)
- …background check, which includes a drug screening. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in ... experience working on clinical trials through every stage of drug development. This includes management and oversight of all...the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years) **For Medical Director… more
- Lilly (IN)
- …functions across the company to leverage learnings, resources, and capabilities. Assurance of Drug Safety Regulatory Compliance + Maintain safety systems to ... around the world. **urpose:** The purpose of the Senior Director - GPS Safety Data Sciences/PV Systems...field or equivalent experience. + 5+ years experience supporting drug development areas (eg, Safety , Clinical, Project… more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... **Description** Director OR Senior Associate Director has responsibility for the pharmacovigilance ...compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:… more
- AbbVie (North Chicago, IL)
- …detection and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Location: Open ... toxicology to effectively conduct safety surveillance. * Responsible for safety surveillance for pharmaceutical / biological / drug -device combination… more
- Astellas Pharma (Northbrook, IL)
- …teams. 1. ** Pharmacovigilance (6 months)** + Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. + Develop ... diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key… more
- Parexel (Dover, DE)
- …Experience with **medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + ... **Medical Director - Gastroenterology Specialty** **Location:** Remote - United...assessments + Contribute medical insights to protocol design and drug development programs + Support pharmacovigilance activities… more
- AbbVie (Jersey City, NJ)
- …trials as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the ... toxicology to effectively conduct safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug -device combined… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Development Scientific Director **Location:** Morristown, NJ Cambridge, MA **About the Job** Join the engine of Sanofi's mission - where deep ... that could turn the impossible into possible for millions. The Development Scientific Director (DSD) is a responsible member of the clinical team dedicated to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major … more
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