- ThermoFisher Scientific (Greenville, NC)
- …to present services to sponsors and prepare effective proposals for Pharmacovigilance and Regulatory Affairs activities which include the specific value proposition ... for the client/sponsor **Management Role:** Manager role with significantly larger management scope (eg global or regional responsibilities or multiple departments) OR mastery of manager skills and responsibilities as demonstrated by consistent, multi-year… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **About the role:** Join Takeda as an Executive Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will ... of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, Therapeutic… more
- Takeda Pharmaceuticals (Columbus, OH)
- …**Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee ... 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 in the preparation… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Pharmacovigilance , Patient Safety , Epidemiology, and Quality (PSEQ) Business Process ... as well as a high level of business acumen specifically in Pharmacovigilance , Individual Case Safety Report Processing, Quality System Management and/or… more
- Kelly Services (Jersey City, NJ)
- …leading organization in the life sciences sector, dedicated to ensuring safety , compliance, and quality through our comprehensive service offerings. Expertise spans ... in pharmacovigilance , medical writing, regulatory affairs, and quality compliance. **Purpose...a CRO or life sciences company, with expertise in pharmacovigilance , medical writing, and medical information. + Demonstrated ability… more
- Ascendis Pharma (Palo Alto, CA)
- …related systems. + Experience from key technical areas, such as: Argus safety solutions, Argus Analytics, Pharmacovigilance Systems, Argus Product Configuration, ... Are you passionate about enabling patient safety with technology? Do you have experience with...Pharma as our new Technical Business Analyst for the Pharmacovigilance IT team. Ascendis Pharma is a fast-growing biopharmaceutical… more
- AbbVie (North Chicago, IL)
- …future opportunities. The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety leads the scientific strategy for ... pharmacoepidemiology and real-world evidence to support product development and safety across therapeutic areas. They will design and interpret studies, contribute… more
- Bayer (Whippany, NJ)
- ** Director Medical Device Safety ** At Bayer...one choice. The Director of Medical Device Safety (MDS) leads and develops global Pharmacovigilance ... Director of MDS is an expert who provides safety oversight and content contributions to design control, clinical...medical device PMS and Vigilance standards within the function Pharmacovigilance (PV), Medical Device Safety (PVMDS) and… more
- BeiGene (San Mateo, CA)
- **General Description:** _The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical ... depending on the program / portfolio being led. The Director , Safety Scientist provides key support as...biological science and 8+ years of experience as a Safety ( Pharmacovigilance ) Scientist. OR MD (or internationally… more
- BeiGene (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
- Lundbeck (Deerfield, IL)
- Medical Director Global Patient Safety (GPS) US - Remote Opportunity Requisition ID: 5424 Location: Deerfield, IL, US Do you want to join a team where the ... the greater United States** **SUMMARY:** This position is responsible for monitoring the safety profile of assigned Lundbeck products according to the FDA and global… more
- AbbVie (Jersey City, NJ)
- …trials as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission - … more
- AbbVie (North Chicago, IL)
- …signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: + ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports. + Apply current… more
- Taiho Oncology (Princeton, NJ)
- …responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety Report ... Sr. Director , PV Medical Surveillance Princeton, NJ, USA Req...+ Minimum of 5 years of experience in a Pharmacovigilance /Drug Safety environment with substantial experience in… more
- ThermoFisher Scientific (Wilmington, NC)
- …to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years) Medical Director level requires: + Clinical ... (comparable to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years). **Qualified candidates should have a… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area ... Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include… more
- Amgen (Washington, DC)
- …for a career you can be proud of. **Global Safety Officer (GSO),** **Global Safety Medical Director - Obesity** **, US - Remote** **Live** **What you will ... and related conditions experience. + 2 years of industry pharmacovigilance (PV) experience + Product safety in...of industry pharmacovigilance (PV) experience + Product safety in the bio/pharmaceutical industry or regulatory agency +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing ... updates or coach direct reports to provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …management experience in PV required - 10+ years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed products required ... and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Board certification is preferred. + A minimum of 6 years' experience in pharmacovigilance with substantial knowledge of drug safety including medical review of ... and IND Safety Reporting. + Industry experience of clinical safety , pharmacovigilance operations, and medical review. Oncology experience preferred. +… more
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