- J&J Family of Companies (Raritan, NJ)
- …field. + Safeguard patient safety. Support Sr. Medical Director in Pharmacovigilance activities, reviewing periodic safety reports and adverse events assessment ... related to biologics. + Engage in environmental scanning and competitive analysis, new product development, clinical research, new business development, product training during investigational trials as well as during product launches, and may provide case… more
- Sanofi Group (Morristown, NJ)
- …customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health ... authorities + Collaborate with marketing teams to link sound evidence to brand strategy + Represent as country medical expert in all product label updates and product Company Core Datasheet (CCDS) updates **Data Generation (15%)** + Work with R&D and Clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ A minimum of 10 years of clinical operations, regulatory, pharmacovigilance , or other relevant biopharmaceutical industry experience, including at least 5 ... years in TMF management and inspection readiness or related position + Mastery of relevant Quality compliance processes and regulations, eg, Good Clinical Practices (GCP) and Good Documentation practices + Mastery of processes related to the maintenance of an… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …alignment amongst relevant functional groups + Review of report from Drug Safety/ Pharmacovigilance , as needed + Preparing for and participating in product Scientific ... Advisory Boards for products both marketed and in development + Complete all company and job-related training as assigned within the required timelines. **Job Requirements:** + Relevant science degree (ie, PhD, PharmD, MD; Master's degree considered based on… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …+ Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on ... an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health,… more
- Daiichi Sankyo Inc. (Basking Ridge, 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 management.… 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) ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all… more
- AbbVie (Florham Park, NJ)
- …role in a TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have an in-depth understanding of ... the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must possess excellent oral and written English communication skills. Ability to interact externally and… more
- Taiho Oncology (Princeton, NJ)
- …cross-functional areas (eg, clinical operations, biostatistics, data management, biomarker, pharmacovigilance , quality, etc.) + Knowledge in authoring key clinical ... development documents (eg, study protocol, IB, ICF, CRF, CSR, DSUR, PBRER, and documents for regulatory interactions). + Ability to learn, integrate complex information, and manage competing priorities for program deliverables + Excellent presentation skills… more
- Sanofi Group (Morristown, NJ)
- …knowledge in one or two domains (eg, Operational experience in Clinical, Pharmacovigilance , Manufacturing, Site Quality Head for a Manufacturing Site, etc.). + ... Previous experience as a Regulatory Authority Inspector. + Member of International Society for Pharmaceutical Engineering (ISPE), BioPhorum, BSI, and/or Parenteral Drug Association (PDA) with working group experience. + French speaking and/or other languages… more