- Nuvalent, Inc. (Cambridge, MA)
- …and company building. The Role: Reporting to the Senior Medical Director, Pharmacovigilance , the Associate Director, Drug Safety and Pharmacovigilance ... required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and… more
- Deciphera Pharmaceuticals (Waltham, MA)
- …board eligible or OUS equivalent) Minimum of 5 years of experience in Pharmacovigilance /Drug Safety with development and marketed products in a biopharmaceutical ... a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office. The Medical Director is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management experience in PV preferredMinimum of 5 years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed products; ... around rare diseases and immune disorders. Job Summary: Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders ... the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance included regulatory document reviewMust have at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in PV; required10 or more years of experience within Drug Safety / Pharmacovigilance experience, including both investigational and marketed products; ... (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases, preferredFamiliarity with Good Clinical Procedures (GCP) and Good… more
- BioSpace (Bridgewater, NJ)
- …identifying trends and implementing corrective and preventative actions. Oversee medical safety and pharmacovigilance activities conducted with external partners ... (TM) lists. Overview The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational and marketed products while spearheading… more
- BioSpace (Boston, MA)
- …in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and ... my knowledge. Job Description About the role: The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …a primary liaison to internal partners (Clinical Operations, Biometrics, Safety / Pharmacovigilance , Regulatory Affairs) and external entities (CROs, third-party ... data vendors) Monitor vendor performance and quality; escalate issues to management and implement corrective actions as appropriate Support audit and inspection readiness activities at the study level Required Qualifications: At least 8 years of experience in… more
- Pharmacy Careers (Huntington Beach, CA)
- Pharmacovigilance Pharmacist Bring your clinical lens to the world of drug safety and reporting. Key Responsibilities: Analyze adverse event reports and clinical ... trial safety data. Prepare regulatory submissions (eg, MedWatch, PSURs). Collaborate...Collaborate with medical affairs and clinical teams to address safety signals. Qualifications: PharmD with strong understanding of pharmacology.… more
- Amgen, Inc. (Philadelphia, PA)
- …to case manage all steps required to gain access to therapy Partner with Safety and Pharmacovigilance (PV). Report Adverse Event (AE)'s and product complaints ... through medical information Maintain case history for all US patients, entering relevant notes from the hub, the pharmacy, calls to insurance, patient support programs, physicians and nurses, and the patients and families Maintain and update patient status to… more
- Nature Careers (Cambridge, MA)
- …and disease-specific risk factors. Contribute to regulatory activities including periodic safety update reports, pharmacovigilance , and risk management plans. ... (conceptual, methodological and statistical) to stakeholders across the company including Safety , Clinical Development, Medical, and Value & Access. The Associate… more
- Formation Bio (New York, NY)
- …regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update ... or relevant subteam, for completion of clinical development and pharmacovigilance related documents. Ensures that clinical, regulatory, and/or pharmacovigilance… more
- Taiho Oncology (FL)
- …defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and align the tactical plan ... for Sr. Manager, Medical Field geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg medical territory plan Training/Education Resource: Develop, maintain and demonstrate scientific expertise… more
- Edgewise Therapeutics (Boulder, CO)
- …leadership across all Clinical Development functions-including Clinical Operations, Pharmacovigilance (PV), Biostatistics, Data Management, and Medical Affairs. The ... understanding of global regulatory requirements governing clinical research and safety , and practical application of Quality Risk Management (QRM) principles.… more
- ProPharma Group (Western Springs, IL)
- …in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance , medical information, and R&D technology, ProPharma offers an end-to-end ... innovate, forward thinking medical guidance and analyze and interpret efficacy and safety data. Working knowledge of FDA and Pharmaceutical regulatory and compliance… more
- Bristol-Myers Squibb Company (New Brunswick, NJ)
- …Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines Contributes to managing ... external communication when significant safety issues arise, with the well-being of patients being the goal Understands and adheres to the BMS Standards of Business… more
- Sanofi Group (Morristown, NJ)
- …clinical development in at least one of the following areas: early development, safety , risk management, pharmacoepidemiology or pharmacovigilance + In depth and ... **Job Title:** PSPV Global Translational Safety Lead **Location** : Cambridge, MA or Morristown,...emerging preclinical data into potential clinical risk + Support Pharmacovigilance teams including Benefit Risk Assessment teams and Translational… more
- Bristol Myers Squibb (San Diego, CA)
- …be the global leader in radiopharmaceuticals . The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of ... + MD or equivalent (MBBS etc) + 10+ years of experience in pharmacovigilance , safety science, or related area within the pharmaceutical/biotechnology industry, +… more
- Rhythm Pharmaceuticals (Boston, MA)
- …As a PV Specialist, you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our ... and safety activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across programs. + Assists in reconciliation… more
- Sanofi Group (Morristown, NJ)
- …Participation in the ongoing permanent inspection preparedness and readiness of Patient Safety and Pharmacovigilance (PSPV) and country PV offices in ... **Job Title:** Pharmacovigilance Audit and Inspection Readiness Expert **Location:** Morristown,...GPV functions. + PV Quality Liaison role for Country Safety Heads / Multi-Country Safety Heads for… more
Related Job Searches:
Associate Director Pharmacovigilance Safety,
Clinical Safety Pharmacovigilance,
Drug Safety Pharmacovigilance,
Drug Safety Pharmacovigilance Associate,
Drug Safety Pharmacovigilance Physician,
Drug Safety Pharmacovigilance Project,
Manager Drug Safety Pharmacovigilance,
Pharmacovigilance,
Pharmacovigilance Drug Safety Director,
Safety