- Vantive (Deerfield, IL)
- …our mission to extend lives and expand possibilities. Your Role at Vantive As the Associate Director , Head of Safety Operations , Safety Systems and Data ... Safety Systems and Data Management. As the Associate Director , you will be part of the Global Patient...pharmacovigilance system and meet expectations. Management of all Safety Operations including Literature, Quality Control, Clinical… more
- Revolution Medicines (Redwood City, CA)
- …pathway. The Opportunity: We are seeking a highly skilled and experienced Executive Director of Safety Surveillance to join our dynamic team. The Executive ... Director of Safety Surveillance is a senior...for the leadership, oversight, strategy, and execution of the pharmacovigilance aggregate reporting process and risk management as it… more
- Ferring Pharmaceuticals (Parsippany, NJ)
- …of results, monitoring program budgets, and ensuring all legal, regulatory and pharmacovigilance requirements are being met. Associate Director will also ... up to the world's oldest enemy: disease. The Associate Director , Patient Access will manage day to day hub...with vendor to prepare ad hoc reports as needed. Pharmacovigilance : Collaborate with vendor and Ferring safety … more
- Olema Oncology (Boston, MA)
- …partners to ensure quality standards are integrated into clinical and safety operations and processes Cross-Functional Collaboration: Collaborate with ... the company. The individual will partner with Research, Clinical Development, Clinical Operations , Drug Safety and Regulatory Affairs functions to drive… more
- BioSpace (South San Francisco, CA)
- …, YouTube , LinkedIn and Tik Tok . Job Description The Medical Director leads the direction, planning, execution, and interpretation of clinical trials or research ... of compliance and regulatory requirements, AbbVies customers, markets, business operations , and emerging issues. Oversees project-related education of investigators,… more
- Neurocrine Biosciences, Inc. (San Diego, CA)
- …protocols, data collection systems, data analysis and final reports. Partners with Drug Safety Pharmacovigilance on adverse event reporting and safety ... clinical studies collaboratively within cross-functional project teams (including clinical operations , preclinical/clinical pharmacology, biometrics, regulatory, drug safety ,… more
- BioSpace (North Chicago, IL)
- …of compliance and regulatory requirements, AbbVies customers, markets, business operations , and emerging issues. Oversees project-related education of investigators, ... integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations ,… more
- Bristol Myers Squibb (San Diego, CA)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Executive Director , Head of Pharmacovigilance - Safety Science, is responsible for ... international PV regulations (eg, FDA, EMA, ICH). + Oversee safety operations team members and vendors in...equivalent (MBBS etc) + 10+ years of experience in pharmacovigilance , safety science, or related area within… more
- Takeda Pharmaceuticals (Boston, MA)
- …by the position's seniority/experience. You will also be involved in signal detection/ safety monitoring activities for pharmacovigilance operations with a ... team, you will report to the Senior Medical Director , GI and work with the broader safety...the most efficient and timelyattainment of compliant and patient-focused safety data. + Represent the pharmacovigilance department… more
- Sumitomo Pharma (Pierre, SD)
- …Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) ... highly motivated, and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will provide hands-on PVRM… 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...teams, as needed. + May serve as delegate for Director as indicated. + Performs other PV activities as… 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 ... ongoing pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and develops an… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the ... in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the ... CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key… more
- Bausch + Lomb (Harrisburg, PA)
- …external consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and ... R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug/Device Safety , and Clinical Supplies),… 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) ... (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within...and external to GPS including senior management. The GPS Director joins Regeneron's industry leading scientific organization, and has… more
- ThermoFisher Scientific (Greenville, NC)
- …find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs ... (comparable to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years) + Experience preference towards individuals… more
- Takeda Pharmaceuticals (Boston, MA)
- …publishing tools, global submission management, labeling platforms, IDMP readiness). Pharmacovigilance Technologies ( safety databases, signal detection, case ... development technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. This role is accountable for shaping and… more
- ThermoFisher Scientific (Greenville, NC)
- …future. **Location/Division Specific Information** Join Thermo Fisher Scientific as a Senior Medical Director based in the United States and be part of a world-class ... required). **Discover Impactful Work:** Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line… more
- Ascendis Pharma (Palo Alto, CA)
- …works closely with Head of GPS Medical Science and Head of Global GPS Operations in activities for monitoring patient safety and provides recommendations and ... . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
