- 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
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …according to prevailing standards + Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal ... and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance … more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. Associate Director/Director, External Collaborations will lead alliance partner relationships ... for Global Patient Safety (GPS) and Global Regulatory Affairs (GRA) operations and lead vendor management for GPS function. This role supports the management of… more
- Merck (West Point, PA)
- …requirements and quality standards. **Preferred Capabilities:** + Understanding of pharmacovigilance , medical affairs, clinical operations and product quality ... will be responsible for managing the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring… more
- Lilly (Indianapolis, IN)
- …may impact a positive benefit-risk balance for a given product. The Associate Director Pharmacoepidemiology Study Operations (AD Ops)is responsible for providing ... support specific studies + Liaise between PE scientists and Research and Development Operations (RD Ops) /Procurement/ Quality in the contracting of PE studies to… more
- ThermoFisher Scientific (Wilmington, NC)
- …Or + Direct experience in medical review and assessment of safety information/ Pharmacovigilance (comparable to 3 years). + Foreign medical degrees may be considered ... GCP) + Understanding of basic biostatistics, data management, and clinical operations procedures + Excellent organizational skills + Ability to work independently,… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director, External Research, Scientific Affairs provides strong subject matter expertise, operational oversight and process requirement ... 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)
- …investigators in their geography + Ensures active collaboration with Region Clinical Operations partners and actively engages in issue escalation and resolution + ... execution of clinical trial support activities (as per established scope documents) ** Pharmacovigilance ** + Ensures that FM team has the required knowledge to… more
- AbbVie (North Chicago, IL)
- …collaboration with a therapeutic area Medical Director or Scientific Director, the Associate Director or Clinical Scientist II, will lead the design, conduct, ... analysis, and reporting of clinical trials. The Associate Director, Clinical Science will apply scientific training and clinical research experience to support all… more
- Merck (Columbus, OH)
- …CRD as needed. + Works in partnership internally with GCTO country operations , finance, regulatory affairs, pharmacovigilance , legal and regional operations ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… 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
- 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 ... EMA and GCP) + Working knowledge of biostatistics, data management, and clinical operations procedures + Ability to act as a mentor/trainer to other staff within… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as chairperson the output of cross-functional evidence team (Clinical Operations , Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, Medical ... Affairs, Market Access, Epidemiology, RWE etc) assuming clinical development & budget responsibility for designated programs, and presents project related proposals and updates to internal governance committees, as well as external bodies (eg, Health… 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
- Amgen (Washington, DC)
- …this. Let's change the world. In this vital role you will be the operations lead for the Amgen Safety Net Foundation that supports specialty pharmacy/retail products ... Senior Manager and Director of Patient Access on PAP operations and will need strong project management skills. The...oversight of program specific PSP at Amgen Inc. (eg pharmacovigilance ). + Ensure efficiency and compliance controls associated to… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive core … more
- Novo Nordisk (Plainsboro, NJ)
- …Legal and IT. This person will provide direct guidance to a team of Associate Managers, intake associate managers and directly and indirectly to case processing ... works closely with counterparts in the GS Departments, including Safety Operations , IT & Quality and Customer Complaint Center. External relationships include… 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
- 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
- Sanofi Group (Cambridge, MA)
- …WSI and TDF + Assisted by related functions (eg clinical operations , project management, and procurement), responsible for timelines, budgets and contingency/risk ... clinical study report + Take on as necessary the Associate CRD role: + Develop the abbreviated protocol +...CRF, e-diary, monitoring plan + Medical support to clinical operations team on study plans: CMP/MRP, DR & DS… more