- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: Oversees Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety ... and AE reporting language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees the… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and process improvement ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director , Patient Services Quality & Process is responsible for overseeing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of ... and other safety reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor on Patient Safety Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documentation and processes are audit-ready and aligned with global pharmacovigilance standards Physical Requirements 0-10% travel required. Development Of People ... and Medical areas, with at least 5-8 years of experience in pharmacovigilance Supervisory management experience of at least five years is preferred SME… more
- Merck & Co. (Rahway, NJ)
- …Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance , Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory ... Operations, Regulatory Submissions, Strategic Thinking {+ 1 more}Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …through strategic vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This job will interact ... Develop and maintain Patient Safety onboarding and on-the-job training for pharmacovigilance employees, while also delivering safety training for internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations, Pharmacovigilance , handling and processing of raw data and external data,… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... the launch timeline.Key responsibilities for the Physician Strategy Role: Support Director HCP PMO to drive foundational customer strategy, leveraging L3 marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... preferred Experience:4 or More Years 5-7 years of relevant experience in pharmacovigilance within the pharmaceutical industry required4 or More Years At least 4… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …safety signals, adverse events, and efficacy data in collaboration with pharmacovigilance teams. Target Product Profile (TPP) Contributions: Develop and refine TPPs ... by outlining desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.Align TPPs with regulatory requirements and commercial goals to guide product development strategies. Due Diligence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with SDEA requirements. Relationships This position reports to the Associate Director , Safety Contracts & Supplier Management. This position works closely with ... Essential Functions Administration: Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of assigned projects in Patient Safety. Relationship Reports directly to the Director , Patient Safety Case Management. This role involves the case handling and ... within the pharmaceutical or healthcare industry. A minimum of 2 year's of pharmacovigilance case processing experience is preferred Experience in patient safety or … more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials ... and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... technology and applying rigorous scientific and ethical standards.The Senior Director (Senior Principal Scientist) has primary responsibility for the planning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance ... globally driven, for the covered processes. Relationships Reports to the Director , Quality Assurance. Interfaces with multiple NNA/S Quality departments and Quality… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and ... integrated Benefit/Risk assessments. **Promote and Advance the Field of Pharmacovigilance ** + Responsible for effective execution, communication and influence with… more
- Arvinas (New Haven, CT)
- …research physician + Partner with Clinical Operations, Translational Medicine, Pharmacovigilance , Data management and other functional team members at assure ... quality and timely study conduct and monitoring + Provide support as needed for clinical and scientific issues that may arise during study execution + Work closely with biostatisticians and programmers to plan analyses of clinical data + Support data summaries… more
- BeOne Medicines (San Mateo, CA)
- …Science Liaison role and an individual contributor role.** **The Field Medical Director (FMD) will support BeOne Pre-Clinical and Clinical pipeline development by ... across the organization. The candidate will report to the Senior Regional Director , Hematology, within Medical Affairs.** **As a leader in the organization, the… more
- Parexel (Baton Rouge, LA)
- …local sponsorship as needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate) Pharmacovigilance Support - Provide ... needs, we are seeking an additional Associate / Medical Director to join Parexel's highly recognized Medical Sciences Team...and Inflammation Therapeutic Franchise! As an Associate / Medical Director , you will work closely with some of the… more
- Organon & Co. (Plymouth Meeting, PA)
- …clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance , Chemistry, Manufacturing and Controls (CMC), medical affairs and ... business development. Non-Clinical Safety Assessment Representative is responsible for strategic and technical contributions to development programs. This position will contribute to design, oversight and execution of the non-clinical toxicology strategy for… more
