- Monster (Bernards, NJ)
- …documents (eg SOPs) as appropriate. Collaborate with cross-functional teams (eg, Medical Safety , Regulatory Affairs, Epidemiology) to ensure benefit-risk ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)… more
- Sumitomo Pharma (Augusta, ME)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will ... PVRM support for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of Rhythm's safety vendor. This position will report to the Director of Pharmacovigilance . Responsibilities and Duties + Reviews adverse event information ... you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of... safety signal detection activities including support of medical safety and safety management… 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 ... minimization activities globally. This role plays a critical role in ensuring the safety and efficacy of our products while also maximizing their value to patients.… 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 ... pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and...on the program / portfolio being led. The Executive Medical Director serves as Product Safety… 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
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will... Safety Board and similar forums. The Senior Medical Director will be a key player… more
- AbbVie (Irvine, CA)
- …preclinical, clinical pharmacy, clinical development, and discovery + Works closely with Executive Medical Director to establish safety strategy for each ... strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans +… more
- Ascendis Pharma (Palo Alto, CA)
- …for process improvements and participate in process optimization initiatives. + Support Medical Safety Science team with activities related to signal detection, ... + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements...with Vendor Management, PV Study Management, QPPV Office and Medical Safety Science teams for assigned activities… more
- Amgen (Thousand Oaks, CA)
- …Amgen 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** ... and review of aggregate reports; Provide oversight to staff with regards to safety in clinical trials including review of SAEs/AEs; Review and provide input and… more
- Takeda Pharmaceuticals (Boston, MA)
- …process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) ... the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the… more
- Ascendis Pharma (Palo Alto, CA)
- …File (PSMF) + Work collaboratively with ICSR Management, Clinical Trial, QPPV office and Medical Safety Science team for assigned activities + Is responsible for ... developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,...desired. + Minimum of 8 years recent experience in Pharmacovigilance + Expert knowledge of FDA safety … 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 (North Chicago, IL)
- …for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic ... and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: *… more
- ThermoFisher Scientific (Wilmington, NC)
- …management and oversight of all contracted services. **Discover Impactful Work:** The Associate/ Medical Director provides medical oversight of clinical ... and/or fellowship), along with patient treatment experience (comparable to 2 years) **For Medical Director Level:** + MD or equivalent required. Active … more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. **Global Safety Medical Director - Hematology/Oncology** **What you will do** ... will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global … more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. **Global Safety Medical Director ** **What you will do** Let's do this. ... of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You… 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). _In some ... safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... 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… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Global Patient Safety (GPS) Lead role ( Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... and recommended risk management and minimization activities. + Ability to utilize GPS safety database for purposes of medical case review and simple queries.… more
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