- Sumitomo Pharma (Trenton, NJ)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... Skills, and Abilities: + Minimum of 8 years of experience in a Pharmacovigilance / Drug Safety environment with experiences in managing adverse event and SAE… more
- Ascendis Pharma (Princeton, NJ)
- …direction of Head of GPS Medical Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio. ... . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate...process definition, monitoring and other roles as required by drug safety to perform the drug… more
- J&J Family of Companies (Raritan, NJ)
- …submission. Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Labeling Product Leader. This position is a hybrid role and can ... be located in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Associate Director , Global Labeling Product Leader will be responsible for the following: + Drive the… more
- Bausch + Lomb (Trenton, NJ)
- …R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug /Device Safety , and ... areas to provide input on study-related documents and issues (DMP, SAP, drug /device supplies, CSR, etc.). + Provides clinical operations input in the identification,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. + **Audit Management:** Oversee the planning, execution,… more
- Edgewell Personal Care (Allendale, NJ)
- …and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and ... Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements....of the consumer products industry. + Experience with OTC drug regulations for FDA, Health Canada, and TGA. Medical… more
- Cardinal Health (Trenton, NJ)
- …Medical Drug Information, including any MSL presentations and Medical/ Safety Review Committees + Provides pharmacovigilance support through collaboration ... to support Cardinal Health customers, the scientific development of radiopharmaceutical drug products, and medical education. This role leverages internal product… more