- Sumitomo Pharma (Augusta, ME)
- …highly motivated, and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will provide hands-on PVRM ... + Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a… more
- Rhythm Pharmaceuticals (Boston, MA)
- …the activities of Rhythm's safety vendor. This position will report to the Director of Pharmacovigilance . Responsibilities and Duties + Reviews adverse event ... you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who...teams, as needed. + May serve as delegate for Director as indicated. + Performs other PV activities as… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee ... and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice...Takeda Safety Board and similar forums. The Senior Medical Director will be a key player in the preparation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Sanofi Group (Cambridge, MA)
- …stakeholders. + Collaborate with Global Project Heads, Clinical Research Director , Safety Officer and Pharmacovigilance , Translational Medicine, Regulatory ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...in helping our teams accelerate progress. The Development Scientific Director (DSD) role in the Neurology Clinical Development department… more
- Lilly (Indianapolis, IN)
- …better for people around the world. **Purpose:** The purpose of the Senior Director - Benefit-Risk Management Group Leader is to lead the development and ... and understanding of regulations, guidelines, and regulatory precedence. The Senior Director will ensure that the Benefit-Risk Management group maintains compliance… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head, Global PV Operations within ... the direction of the Head, Global PV Operations, the Director , ICSR Management Team is responsible for the oversight...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , PV Vendor Management Team reports to the Director , Head, PV Vendor ... the assigned Vendor Management activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and… more
- Actalent (Frederick, MD)
- Description Quality Assurance Director with extensive experience in biopharmaceutical quality assurance and management of quality programs for clinical cell therapy ... motivated professional who can oversee Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP, GLP, and PV operations,,… more
- AbbVie (Irvine, CA)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: Group Medical Director manages other Associate Medical Directors, Medical Directors, Senior ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-oncology… more
- Takeda Pharmaceuticals (Boston, MA)
- …empower you to shine? Join us as a PV Risk Management Scientist/Associate Director . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven ... for excellence in everything we do. As an Associate Director / PV Risk Management Scientist, being part of our...Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety +… more
- AbbVie (North Chicago, IL)
- …evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: * Understanding ... combination products. * Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory… more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face… more
- Amgen (Thousand Oaks, CA)
- …team. Join us and transform the lives of patients while transforming your career. ** Director Global Safety** **What you will do and what we expect of you** Let's ... with department heads to implement new and revised processes and pharmacovigilance standards across the divisions/groups; Support product team in performing data… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the quality ... compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by… more
- ThermoFisher Scientific (Wilmington, NC)
- …find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in ... oversight of all contracted services. **Discover Impactful Work:** The Associate/Medical Director provides medical oversight of clinical trials to ensure company… more
- ThermoFisher Scientific (Greenville, NC)
- …REMS, RMP and CSR). **General Support:** Ensures tasks delegated to pharmacovigilance are properly executed. Adheres to applicable regulations and ICH guidelines ... to 1-2 years) in the industry; Or + Direct experience in safety/ Pharmacovigilance medical monitoring (comparable to 2 years). _In some cases an equivalency,… more
- IQVIA (Durham, NC)
- **J** **ob Overview** The Associate Medical Director / Medical Director will provide medical, clinical and scientific advisory expertise to all IQVIA divisions ... review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department. + May provide medical support for the Analysis of Similar… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring the compliance ... Clinical Program Quality team and share insights to trends to Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation… more
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