- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Functions Administration: Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing ... ensure compliance with SDEA requirements Supports development and maintenance of Pharmacovigilance System Master File (PSMF). Ensures accuracy and completeness of… 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 6-8 years of experience in pharmacovigilance Supervisory management experience & Leading Therapeutic Areas and teams preferred SME… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the pharmaceutical or healthcare industry. A minimum of 2 year's of pharmacovigilance case processing experience is preferred Experience in patient safety or ... pharmacovigilance preferred Knowledge of medical terminology required Knowledge of NovoNordisk supported disease states preferred (eg, diabetes, obesity, hemophilia,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance Must have proficiency in ICH GCP Guidelines, US and ... and employeesExpertise working within early development through Phase III and Pharmacovigilance studies preferred Travel:Must have the ability to travel up to… 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 ... function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control. Additionally, this role provides SME-level input from the affiliate perspective when required. This role also provides direct support for continuous… 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 surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight of clinical research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …healthcare industry, with at least 4 years in patient safety or pharmacovigilance 3 years' experience in peer-to-peer coaching / mentoring preferred Exceptional ... knowledge of medical terminology required Knowledge of USO supported disease states preferred (eg, diabetes, obesity, hemophilia, growth hormone disorders) Analytical thinking skills required Experience with Drug Safety database preferred Strong oral and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Develop and maintain Patient Safety onboarding and on-the-job training for pharmacovigilance employees, while also delivering safety training for internal and ... external stakeholders Design and implement comprehensive compliance training programs tailored to CMR personnel, ensuring effective learning and adherence to GxP standards Maintain learning management systems and track training completion rates to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations, Pharmacovigilance , handling and processing of raw data and external data, ... CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working in fast-paced environment, continuous improvement, project management, change management, and risk… 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 ... drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director (Senior Principal Scientist) has… more
- Formation Bio (New York, NY)
- …Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary ... responsibilities for the Vice President of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development activities at… more
- Daiichi Sankyo, Inc. (Louisville, KY)
- …and the marketing team to the District Manager.Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21, Reporting ... Adverse Events (AEs) and Product Quality Complaints (PQCs).' Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's ... agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US… more
- Aequor (Thousand Oaks, CA)
- …60601and IEC/EN 62304) Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities Ability to read, analyzes, and interprets general ... business periodicals, professional journals, technical procedures, or governmental regulations Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs Proficient working on multiple projects in a… more
- Merck & Co. (Montgomery County, PA)
- …liaison with commercial, medical affairs, market access, legal/compliance, pharmacovigilance , and external partners to ensure integrated program deployment.Develop ... and maintain relationships with specialty pharmacies, infusion centers, provider networks, patient advocacy groups, and third-party vendors.Partner with legal and compliance to review promotional and non-promotional materials, financial assistance programs and… more
- Insmed Incorporated (NJ)
- …complaints received by MI staff are forwarded to Insmed's Pharmacovigilance and/or Quality Assurance Department, respectivelyMedical Information - Medical ... Reviewer:Medical reviewer for the medical and commercial review committeesWho You Are:An advanced degree is required (eg PharmD, MD, PhD)4+ years working in a Medical Information capacity at a pharmaceutical or biotech company (other relevant experience… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... years of experience in PV signal detection required1 or More Years 3 years of experience collaborating on global project teams requiredExperience with safety databases and signal detection platforms requiredExperience in global PV inspection and/or audits… more
