- Deciphera Pharmaceuticals (Waltham, MA)
- …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 ... responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources… more
- Nuvalent, Inc. (Cambridge, MA)
- …and company building. The Role: Reporting to the Senior Medical Director, Pharmacovigilance , the Associate Director, Drug Safety and Pharmacovigilance Scientist ... the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management… more
- BioPharma Consulting JAD Group (Cambridge, MA)
- The Senior Manager, Global Pharmacovigilance (PV) Quality Assurance is a key member of the GVP QA team, providing global quality oversight of post-marketing ... pharmacovigilance systems. This includes ensuring compliance with EMA Good Pharmacovigilance Practices (GVP) Modules, FDA regulations, and other international PV… 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 with medical affairs and clinical teams to address safety signals. Qualifications: PharmD with strong understanding of pharmacology. Prior experience in drug safety or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety ... and AE reporting language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders for key Health Authority ... Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or… more
- Formation Bio (New York, NY)
- …regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update reports) by ... or relevant subteam, for completion of clinical development and pharmacovigilance related documents. Ensures that clinical, regulatory, and/or pharmacovigilance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PV; required10 or more years of experience within Drug Safety/ Pharmacovigilance experience, including both investigational and marketed products; preferredExtensive ... safety databases, preferredFamiliarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) preferred Daiichi Sankyo, Inc. is an equal… more
- Taiho Oncology (FL)
- …Respond to unsolicited medical information requests in the field. Fulfill Pharmacovigilance responsibilities as 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… more
- Edgewise Therapeutics (Boulder, CO)
- …leadership across all Clinical Development functions-including Clinical Operations, Pharmacovigilance (PV), Biostatistics, Data Management, and Medical Affairs. The ... Clinical Development functions - including Regulatory Affairs, Clinical Operations, Pharmacovigilance , Biostatistics, Data Management, and Medical Affairs - to… more
- BioSpace (Boston, MA)
- …compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by ... and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance -related change controls. Provides data insights to emerging regulations… more
- BioSpace (Bridgewater, NJ)
- …corrective and preventative actions. Oversee medical safety and pharmacovigilance activities conducted with external partners including contract research ... across multiple time zones and regions. Significant experience in Global Pharmacovigilance with proven understanding of global PV regulations, GVP Requirements, and… more
- Amgen, Inc. (Philadelphia, PA)
- …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 track… 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
- BioSpace (North Chicago, IL)
- …sources (biomarker/translational, big data, digital sources, real world data, pharmacovigilance data, clinical trial data) Responsible for coaching and mentoring ... junior team members. May include indirect supervision of employee and contract staff Drive the definition, design, implementation and validation of cutting-edge algorithms to analyze disparate data sources to achieve targeted outcomes by leveraging advanced… 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 ... suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Essential Functions: Draft high-quality, complex contracts, change orders and associated deliverables. Develop accurate… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …by collaborating with cross-functional teams. Partner with medical, regulatory, pharmacovigilance , pharmacology, clinical operations, and other functions to ensure ... appropriate statistical methodologies and analysis plans are implemented across all clinical studies. Champion the adoption of innovative statistical approaches (eg, adaptive, seamless, Bayesian designs) to enhance trial efficiency, optimize resource… more
- Nature Careers (Cambridge, MA)
- …to regulatory activities including periodic safety update reports, pharmacovigilance , and risk management plans. Collaborate cross-functionally for evidence ... generation planning and execution. Who You Are You enjoy designing and interpreting observational studies and are happy to work collaboratively with different functions. Required Skills PhD or ScD in Epidemiology is required. 2+ years' experience in a… 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 ... suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. The Medical Promotional Review Consultant is responsible for: Providing compliant, medically accurate and scientifically… 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 Conduct and Ethics, all Company policies and procedures including those that apply to all… more
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