- Novo Nordisk Inc. (Plainsboro, NJ)
- …Microsoft Word, Excel and Outlook required Experience with a Call Center and Drug Safety database preferred Strong oral and written communication skills required ... for ensuring compliance is met with all internal and external (eg FDA) drug and device safety reporting regulations. Relationships Reports to Patient … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThe Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists ... various regions, offering guidance and support to each product safety team in critical areas such as individual case...expectedness of the adverse event in relation to the drug . Ensure all relevant data and findings are incorporated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and other vendors to ensure high quality ... possesses advanced knowledge of medical terminology capture and reporting of safety data, pharmacovigilance , industry best practices, and relevant regulatory… more
- System One (Madison, NJ)
- …Life Sciences, Information, or similar background (Bachelors, Masters) + 5+ years Drug Safety / Pharmacovigilance experience + Advanced Tableau, Spotfire, ... Job Title: Pharmacovigilance Reporting Analyst Location: Lawrenceville, NJ Hours/Schedule: Hybrid...Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug ) + Strong PowerPoint, Word, and Excel Skills +… more
- Ascendis Pharma (Princeton, NJ)
- …2 days remote. Key Responsibilities + Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance ... information pertinent to product safety . + Supports the development of safety surveillance and risk management plans for drug development programs. +… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …+ Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance , SVP Late Clinical Development and the ... working closely with other functional areas such as commercial, regulatory, pharmacovigilance , CMC, early clinical and pre-clinical development in this regard. The… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …+ Ensuring 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… more
- Nestle (Bridgewater, NJ)
- …Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering ... automation, regulatory compliance, quality management and compliance, medical information, or clinical trials applications. + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical… more
- 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
- United Therapeutics (Trenton, NJ)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
