- Albireo Pharma, Inc. (Boston, MA)
- …2019 Best Places to Work in Massachusetts. Job Description Job Title: Associate Director Drug Safety and Pharmacovigilance (DSPV) Reports To: Sr. ... Director of Drug Safety and Pharmacovigilance Location: Boston Position Summary: A broad-based pharmacovigilance role including oversight of outsourced… more
- Unknown (Boston, MA)
- …the 2019 Best Places to Work in Massachusetts.Job DescriptionJob Title: Associate Director Drug Safety and Pharmacovigilance (DSPV)Reports To: Sr. ... Director of Drug Safety and PharmacovigilanceLocation: BostonPosition Summary: A broad-based pharmacovigilance role including oversight of outsourced case… more
- Omeros Corporation (Seattle, WA)
- Good things are happening at Omeros! Manage and oversee global drug safety / pharmacovigilance processes including the collection, safety review, processing, ... global pharmacovigilance collaborators to ensure maintenance of regulatory pharmacovigilance compliance Has primary responsibility for periodic safety … more
- Baxter (Compton, IL)
- …are adhered to (MHRA, HPRA). Essential Duties and Responsibilities The PV Pharmacovigilance Associate is accountable and responsible for the following ... Job Description Summary The Pharmacovigilance Senior Associate for UK, Ireland... related issues without delay, In coordination with the Pharmacovigilance Director , to support implementation of corrective… more
- Akorn, Inc (Cranbury, NJ)
- The Associate Director , Pharmacovigilance / Product Surveillance has responsibility for the pharmacovigilance risk management activities of commercial, ... Management Plans Clinical Overview Statements * Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk… more
- Unknown (Foster City, CA)
- …risk minimization and PV measures, as applicable, in collaboration with Pharmacovigilance & Epidemiology PhysiciansContributes to development and execution of Risk ... and strategic input in development and execution of Post Authorization Safety Studies (PASSs), including Long-term follow up/Registry studiesParticipates in or may… more
- FMD K&L (Fort Washington, MD)
- Title: Associate Director / Director , Contract/Budget Management Location: Fort Washington, PA Job Type: Full-time onsite Reporting to : Executive Director ... data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety , pharmacovigilance , toxicology, medical affairs, medical writing,… more
- Unknown (Cambridge, MA)
- …be a vital contributor to our inspiring, bold mission. As a Associate Director Risk Management, working on the Pharmacovigilance team, you will be empowered ... of your future at Takeda. Join us as a Associate Director , Risk Management in our Cambridge...product benefit-risk across therapeutic areas within Takeda Global Patient Safety and Evaluation (GPSE)Advise on the strategy, preparation and… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …Purpose/Objective of the job Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described. Act as project-specific liaison between ... CT&S and key stakeholders, includingGlobal Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel,monitoring the status of the project(s) to… more
- Santen, Inc. (Emeryville, CA)
- …result in the regulatory approval of the compound in multiple regions. The Associate Director creates all types of clinical regulatory documents (eg, protocol, ... us meet our aggressive and important goals. ABOUT THE POSITION: The Director , Global Clinical Science (GCS) supports the strategy for Global Clinical Development… more
- AbbVie (North Chicago, IL)
- …signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Key Responsibilities ... pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans Apply current regulatory… more
- Daiichi Sankyo (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... veteran status, age, or any other characteristic protected by law. Job Title Associate Director , Regulatory Affairs Labeling City Basking Ridge Functional Area… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …transformative business results. Summary TheOncology Lead reports to the Head of Global Safety Risk Management (GSRM) and manages a team of 2 GSRM Implementation ... Managers, the GSRM Document Manager, and the GSRM Associate in order to support development and effective implementation...quality standards. Responsibilities Serve as a bridge between the Safety Management Team (SMT) and the International PV Team… more
- AbbVie (Green Oaks, IL)
- …please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn. The Associate Director , Epidemiology is a leader and technical expert in the ... Global Epidemiology group in Pharmacovigilance & Patient Safety . This person will...strategy. Some key areas of contribution expected for the Associate Director include: (a)proposing strategic solutions regarding… more
- AbbVie (Green Oaks, IL)
- …accountability. Strategically develops responses to employee relationship trends In absence of Associate Director , is responsible for Associate Director ... communicates case processing and reporting policy and direction for Global Product Safety . Evaluates new regulations and guidelines, develops plans and processes for… more
- FMD K&L (Fort Washington, PA)
- Title: Associate Director / Director , Contract/Budget ManagementLocation: Fort Washington, PAJob Type: Full-time onsiteReporting to: Executive Director , ... data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety , pharmacovigilance , toxicology, medical affairs, medical writing,… more
- Genentech (San Francisco, CA)
- …& are dedicated to remaining a great place to work. Hiring / Find A Job Safety Science Associate Group Director South San Francisco California, United States ... and seniority, who operate in support of complex scientific safety and pharmacovigilance (PV) activities across all Roche assets throughout the lifecycle.… more
- AveXis Inc. (Bannockburn, IL)
- …lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Associate Director of Medical Information reports to the Senior Director ... teams. Authors insight reports based on medical inquiries received. Collaborates with pharmacovigilance and product supply to ensure timely processing of potential … more
- Unknown (Lexington, MA)
- …domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Associate Business Development Director Safety & Regulatory ... SolutionsLocation: US Greater Boston area, NY/NJ, VA/DC Metro, CA areasThe Associate Business Development Director works collaboratively with other colleagues to… more
- AbbVie (Green Oaks, IL)
- …areas: Clinical Pharmacology, Medical Affairs,Clinical Development, Regulatory Affairs and Pharmacovigilance and Patient Safety . With supervision, participates ... study integrity, review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is… more
