- Sanofi Group (Cambridge, MA)
- Head of Pharmacoepidemiology Vaccines, Patient Safety Pharmacovigilance (PSPV), provides scientific and strategic leadership in epidemiology to demonstrate ... vaccines safety. The Head is accountable for defining the overall strategy, the...Risk evaluation, and to support internal decision making. The Head is the leading expert in the best practices… more
- Boehringer Ingelheim (Athens, GA)
- **Description** The AD Global PV Data Analysis supports the Global Pharmacovigilance (PV) team to ensure compliance with all regulations and laws worldwide on ... Pharmacovigilance (including but not limited to FDA 21 CFR,...for our employees. **Duties & Responsibilities** + Together with Head of PV Operations, establish and maintain scientifically valid… more
- Mallinckrodt Pharmaceuticals (Jobe, MO)
- Job Title 安全管理（ファーマコビジランス）業務従事者/Senior Specialist, Pharmacovigilance Requisition JR000012874 安全管理（ファーマコビジランス）業務従事者/Senior Specialist, Pharmacovigilance (Open) ... + 入手した安全管理情報の処理（評価・安全性データベースへの入力・評価資料の作成・フォローアップ等）: 使用する安全性データベースはGlobal safety databaseであり、入力言語は英語 + 安全性評価／安全対策に係る案件に関する当社Global Head QuarterのPVチーム及び国内提携会社との協議、業務の推進 + 規制当局へのICSR報告 + 安全管理情報中の品質関連情報・外国における措置情報のモニタリング +… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **Job Title** : Head , Clinical and Safety Quality Compliance **Location** : Cambridge, MA or Zurich, ... Switzerland **About the role:** + Leads the global Clinical, Pharmacovigilance , and Medical Quality Compliance organization, providing quality oversight...and Global Regulatory Affairs (GRA). + Reports to the Head of CPMQ and is a key member of… more
- Sanofi Group (Bridgewater, NJ)
- **CHC Case Management Head ** **Location:** Bridgewater, NJ **Remote Work:** Hybrid **Travel Expected:** ~10% (domestic and international) **Job Type:** Full time ... of the CHC PV Operations team and reports to the CHC PV Operations Head . This position includes responsibilities of Case Medical Safety lead The position is the… more
- Sanofi Group (Bridgewater, NJ)
- …in the clinical and commercial development of all products in it. The Medical Head of RSV Franchise is a true business partner offering valuable medical expertise in ... RSV in accordance with internal procedures and applicable regulations. The Medical Head assures the delivery of the medical strategy plan and scientific activities,… more
- Sanofi Group (Swiftwater, PA)
- ** Head (Associate Vice President) Global Clinical Franchise RSV Older Adult** **LOCATION** The role can be located in Swiftwater, PA or Lyon, France. 2-3 days of ... can be viewed here (https://www.sanofi.com/en/our-science/our-pipeline) . **ABOUT THE ROLE:** The Head of Global RSV Older Adult Clinical Franchise reports to the… more
- Amgen (Thousand Oaks, CA)
- …turn the tide of serious, life-interrupting illnesses. **Executive Director, Global Safety Head , Obesity** **Live** **What you will do** Let's do this. Let's change ... the world. In this vital role as the Executive Director, Global Safety Head , you will serve as the safety expert for Amgen's obesity products globally and are… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …compliance with evolving global regulatory requirements and with company objectives. The Head of GRA Global Labeling leads a team of labeling strategists, labeling ... (including global and regional leaders from Supply Chain, Clinical Safety Pharmacovigilance , Commercial, Medical Affairs and Legal) to ensure accurate and… more
- J&J Family of Companies (Horsham, PA)
- …benefit/risk. The MSO will report to the GMS Sr. Director Product Safety Head , Oncology and oversee the safety and benefit/risk assessment of assigned products ... known risks and changes to benefit/risk, when appropriate, to the Sr. Director Product Safety Head , the VP Therapeutic Area Safety Head (TASH), the Head of… more
- Sanofi Group (Bridgewater, NJ)
- **Regional PV Manager** Internal posting title: Deputy Country Safety Head , US and Canada **Location:** Bridgewater, NJ **Remote Work:** Hybrid **Job Type:** Full ... of absence of the CSH). **Main Responsibilities** **The CHC PV Deputy** **Country Safety Head (DCSH)** + Supports the Country Safety Head in country related PV… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the Senior Medical Director Marketed Products (SMDMP) you will report to the Head of Global Clinical Science, Marketed Products Group and are accountable for Medical ... and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance , global development operations and project management) to set R&D… more
- AbbVie (North Chicago, IL)
- …for early oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting ... to clinical safety, and will be interpreting regulations related to pharmacovigilance to support all patient safety activities. Responsibilities: + Understanding and… more
- AbbVie (South San Francisco, CA)
- …late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting ... as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety… more
- Merck (Columbus, OH)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager… more
- Sanofi Group (Bridgewater, NJ)
- …Department, and within the guidelines given by the Global Clinical Franchise Head , the Global Clinical Development Strategy Expert (GCDSE) is a key member ... and medical scrutiny. + The candidate will report to the Global Clinical Franchise Head for Pneumo & New Targets and will in principle be responsible for projects… more
- Merck (Columbus, OH)
- …event reporting requirements internally and externally. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research ... produce safe, effective, innovative medicine. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for… more
- Amgen (Washington, DC)
- …this vital role you will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all ... and or setting the strategy, direction, and priorities of pharmacovigilance activities. + Manage Medical Directors, Associate Med Directors,...Can act as delegate for the TAH (Therapeutic Area Head ) as needed. **Win** **What we expect of you**… more
- Merck (Columbus, OH)
- …- Oncology** With support of other Clinical Research Manager's (CRMs) and/or TA- Head /CRD, this role is accountable for the end-to-end performance and project ... in assigned studies. + Escalates as needed different challenges and issues to TA- Head /CRD/CCQM and or CTT (as appropriate). + Identifies and shares best practices. +… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Head of the Late-Stage Clinical Development organization is a member of the Organon Research and Development (R&D) ... Leadership team, reporting to the Head of R&D and Chief Medical Officer, and is...efficient and in line with Good Clinical and Good Pharmacovigilance Practice (GCP and GPvP). + Ensure excellent understanding… more