- Astellas Pharma (Cambridge, MA)
- …with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of ... specialty publications. -Play a strategic lead role in collaboration with Pharmacovigilance /Medical Safety to ensure optimal standards, processing, collection,… more
- Astellas Pharma (Northbrook, IL)
- …with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of ... Affairs and Early Development and Translational Sciences. + Partner with Pharmacovigilance /Medical Safety Leads to ensure optimal standards, processing,… more
- Sanofi Group (Waltham, MA)
- …(CROs) + Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, safety surveillance) + ... May represents Sanofi Vaccines BIOS group externally in interactions and meetings with Regulatory Authorities, expert panels, statistical experts, independent data monitoring committees + May act as the lead statistician at clinical trial level and provides… more
- Ascendis Pharma (Palo Alto, CA)
- …Safety Database. + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure ... the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head,...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- BeOne Medicines (San Mateo, CA)
- …ongoing pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and develops an ... GPS product co-ordination, chairs product group meetings across GPS ** Pharmacovigilance :** + Leads and manages safety PV...across GPS ** Pharmacovigilance :** + Leads and manages safety PV processes for BeiGene and competitor products +… more
- Sumitomo Pharma (Bismarck, ND)
- …and effectiveness checks. + Contributes to standard operating procedures relevant to pharmacovigilance . + Assist with other Safety department activities as ... (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will...Manager works closely with the Information Management (IM) and Safety Science groups as part of a matrix team… more
- United Therapeutics (Research Triangle Park, NC)
- …currently an option. **Who you are** We are seeking an experienced Senior Product Safety Scientist to join our dynamic pharmacovigilance team. You will play a ... key role in managing the safety profile of our products by supporting signal detection,...safety perspective + Intermediate to advanced knowledge of pharmacovigilance processes and regulatory requirements + Advanced knowledge of… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance ... role requires a strategic business leader with experience in leading patient safety areas, proven abilities with team development, in depth understanding of … more
- Takeda Pharmaceuticals (Boston, MA)
- …relating to studies in assigned compounds. + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of ... record for assigned compounds. + Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. + Responsible for evaluation of external interactions in… more
- United Therapeutics (Research Triangle Park, NC)
- …+ 5+ years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety and Medical Science, ... background in nursing or pharmacy and you're passionate about pharmacovigilance . You are a team player who loves quality,...are implemented and successful. This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality,… more