- Genentech (South San Francisco, CA)
- …participant recruitment and retention, decentralized trials, patient safety, pharmacovigilance , informed consent, research privacy, clinical contracting, etc.); + ... Biomarker, genomic research and emerging data and digital solutions pertinent to R&D + Real World Data and secondary use of research data; and + Pre-approval and expanded access to investigational medicinal products and/or medical devices. + Serving as lead… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …marketing for key products. + Continuously develop knowledge of regulatory, pharmacovigilance , and quality assurance requirements in alignment with BD Practice ... Standards. **Required Qualifications** + Minimum 5 years of experience in clinical practice + Knowledge of Good Clinical Practice (GCP) + Ability to identify unmet clinical needs and evaluate product opportunities from a clinical perspective + Strong critical… more
- ThermoFisher Scientific (Carlsbad, CA)
- …effectively with key internal directorates including Operations, Biometrics, Regulatory, Pharmacovigilance , and Global Product Development to ensure the best ... proposals and plans are developed for clients. + Ensures the proper level of scientific support is delivered in the award and execution process + Promotes innovation and works with Global Medical Officer PPD Biotech to move PPD in a direction to be more… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Quality/Compliance experience. + Advanced knowledge of clinical research (GCP), pharmacovigilance (GVP) and medical throughout R&D and commercialization, and ... relevant regulations. + Preferably with experience in strategic roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation activities on a global level and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …every clinical study + **Qualification and periodic assessment of clinical and pharmacovigilance vendors participating in the clinical studies** + Perform a quality ... assessment (including a risk assessment) of all the vendors selected as candidates to participate in the clinical studies + Qualify the clinical vendors before their participation in the clinical studies and re-qualify them when applicable + Perform an annual… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. + Makes final decisions regarding study conduct related to scientific integrity. + **External Interactions** + Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …and Development, strategy/portfolio management, Regulatory Affairs, and Pharmacovigilance . External collaboration includes trade associations, professional ... societies, payers, clinicians, and policy thought leaders, and various government personnel and agencies. Collaboration across a matrix organization is critical. Working Conditions: + Hybrid work schedule at our Bridgewater, NJ office preferred. Open to… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + ... Ability to work with a safety system database for purposes of medical case review and simple queries + Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize + Ability to effectively communicate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …/ combination product safety or related experience. Previous experience in pharmacovigilance and device safety activities. + Thorough understanding and application ... of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle. Experience translating these… more
- Astellas Pharma (Northbrook, IL)
- …statistics, medical affairs statistics, real-world evidence (RWE), safety/ pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and ... advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key… more