- 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
- 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
- Merck (Rahway, NJ)
- …Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines ... Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study… 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