- 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,...**Duties & Responsibilities** + Together with Head of PV Operations , establish and maintain scientifically valid ongoing safety surveillance… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...team members. + Maintain training and oversight to clinical operations / pharmacovigilance vendors supporting pharmacovigilance activities,… more
- Merck (Columbus, OH)
- …team (eg Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory ... **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety...trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality … more
- Lilly (Indianapolis, IN)
- …which may impact a positive benefit-risk balance for a given product. The Associate Director Pharmacoepidemiology Study Operations (AD Ops)is responsible for ... + Liaise between PE scientists and Research and Development Operations (RD Ops) /Procurement/ Quality in the contracting of...vendor selection decisions. + Work closely with PE Sr Director and/or delegates to identify operational gaps & drive… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director , External Research, Scientific Affairs provides strong subject matter expertise, operational oversight and process ... continuous improvement and customer experience mentality to refine processes and operations that support an evolving healthcare market. + Maintains expert knowledge… more
- Bristol Myers Squibb (Chicago, IL)
- …and spirit of independence and love of challenge. **Job Description** The Region Director (RD) is a remote leadership position that is primarily responsible for ... satisfaction and productivity. This position reports into a national Field Medical Director role. The RD position is underpinned with the expectation of leadership… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. **Summary** The Associate Director , External Data Management, is accountable for the ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and External Vendors for the data services they provide to… more
- ThermoFisher Scientific (Wilmington, NC)
- …to 1-2 years) in the industry. + Direct experience in safety/ Pharmacovigilance (comparable to 2 years). + Candidates with industry experience(CRO/Pharma) maybe ... considered for Medical Director /Senior Medical Director level. _In some cases...+ Working knowledge of biostatistics, data management, and clinical operations procedures + Ability to act as a mentor/trainer… more
- ThermoFisher Scientific (Wilmington, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety/ Pharmacovigilance (comparable to 2 years). _Additional experience required for Sr Med ... Director level. Experience should be industry_ _specific(CRO/Pharma)._ _Management/Leadership_ _experience...+ Working knowledge of biostatistics, data management, and clinical operations procedures + Ability to act as a mentor/trainer… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as chairperson the output of cross-functional evidence team (Clinical Operations , Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, Medical ... requirements and global regulatory and ethical standards. **Requirements** **Requirements for Director Level:** + MD and retinal specialist from an accredited… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance , Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research,… more
- Novo Nordisk (Plainsboro, NJ)
- …to case processing activities. Relationships Reports to the Executive Director , NAO Patient Safety with cross-functional working relationships within Medical, ... person will provide direct guidance to a team of Associate Managers, intake associate managers and directly...closely with counterparts in the GS Departments, including Safety Operations , IT & Quality and Customer Complaint Center. External… more
- Sanofi Group (Cambridge, MA)
- **Clinical Research Director - allergy-immunology-dermatology** The Clinical Research Director (CRD) is noted as the **primary clinical expert for programs** . ... and TDF + Assisted by related functions (eg clinical operations , project management, and procurement), responsible for timelines, budgets...clinical study report + Take on as necessary the Associate CRD role: + Develop the abbreviated protocol +… more
- AbbVie (North Chicago, IL)
- …compliance and regulatory requirements, AbbVie's customers, markets, business operations , and emerging issues. Oversees project-related education of investigators, ... data pertaining to safety and efficacy of the molecule. Along with Clinical Operations , is responsible for oversight of study enrollment and overall timelines for… more
- AbbVie (Mettawa, IL)
- …of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. Oversees project-related education of investigators, ... safety and efficacy of the molecule. Along with Clinical Operations , is responsible for oversight of study enrollment and...other program documents. + May oversee the work of Associate or Assistant Scientific Directors and of Clinical Scientists… more
- Novo Nordisk (Plainsboro, NJ)
- …efforts, and pre-launch planning for pipeline assets. Relationships Reports to Associate Director / Director , Strategic Market Insights. Supports current ... About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to… more
- Amgen (Washington, DC)
- …to the Board of Directors. The Manager will collaborate with the Senior Manager and Director of Patient Access on PAP operations and will need strong project ... world. In this vital role you will be the operations lead for the Amgen Safety Net Foundation that...oversight of program specific PSP at Amgen Inc. (eg pharmacovigilance ). + Ensure efficiency and compliance controls associated to… more
- Merck (Austin, TX)
- …safe, effective, innovative medicine. The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter expert in CDISC ... **Job Description** Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare...your employment may pose an undue burden to business operations , in which case you may not be offered… more