- Astellas Pharma (Northbrook, IL)
- …present data, strategy and risk assessment. **Preferred:** + 5 years' experience in drug safety or pharmacovigilance is preferred + Early Development ... Following entry into development, the EDSP serves as the drug safety lead on the Asset Team,...Quality Framework. + Provides effective communication and training to pharmacovigilance teams (eg, Safety Science, Epidemiology, Operations)… more
- US Tech Solutions (Madison, NJ)
- …Life Sciences, Information, or similar background (Bachelors, Masters) * 5+ years Drug Safety / Pharmacovigilance experience * Advanced Tableau, Spotfire, ... **Title:** ** Pharmacovigilance (PV) Analytics and Reporting Specialist** **Duration :...Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug ) * Ability to organize/curate data and see big… more
- AssistRx (Maitland, FL)
- …Life Sciences, etc.) or equivalent experience required. + 7+ years of experience in pharmacovigilance / drug safety , with 3+ years in a compliance, oversight, ... The Manager, Pharmacovigilance - Front End Operations will lead frontline...to ensure consistent alignment with global regulatory requirements for drug safety , reporting, and risk management. This… more
- System One (Jersey City, NJ)
- …Manager, Project Management is responsible for providing support to regional and global Drug Safety Pharmacovigilance (PV) projects. Projects include global ... Notes: Seeking someone with project management experience and has working knowledge of Drug Safety , MS Project and MS Excel. POSITION OVERVIEW/SUMMARY The Senior… more
- Ascendis Pharma (Palo Alto, CA)
- …Key Responsibilities . Assists Head of Global Medical Safety Science for drug safety and pharmacovigilance activities for ensuring corporate compliance ... Head of Global Medical Safety Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio.… more
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... and Abilities: + Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial experience in managing adverse event… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of professional management experience in PV required - 10+ years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed ... and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that… more
- Takeda Pharmaceuticals (Columbus, OH)
- …preferred. + At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major … more
- Bausch + Lomb (Rochester, NY)
- …Person for consumer-related issues escalated by team members + Manage communication within Drug Safety ( Pharmacovigilance ) email box + May collaborate with ... other sources to respond to the post or answer any questions: Regulatory- Pharmacovigilance , R&D, all other Bausch + Lomb sites worldwide, Marketing, Legal + Log… more
- Amgen (Thousand Oaks, CA)
- …interdepartmental & international programs and projects + Understanding of international drug safety regulations, global pharmacovigilance and product ... + Previous product safety experience and knowledge of clinical trials and drug development + Knowledge of patient populations and drug classes + Issue… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Management, Risk Management & Benefit Risk, Medical Review and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory requirements worldwide ... Signal Management, Risk Management & Benefit Risk, and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory...required by regulatory authorities to monitor and assess the safety profile of a drug + Communication… more
- Amgen (Washington, DC)
- …with these qualifications. **Basic Qualifications:** Doctorate degree and 2 years of safety / pharmacovigilance experience OR Master's degree and 4 years of ... guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO... safety / pharmacovigilance experience OR Bachelor's degree and... safety / pharmacovigilance experience OR Bachelor's… more
- CSL Behring (King Of Prussia, PA)
- …with 10+ years of pharmaceutical/biotherapeutics industry experience + Experience in drug safety , pharmacovigilance , quality assurance and compliance ... requirements is desirable. + 5+ years of Medical Affairs Leadership experience + Experience building and leading matrixed teams in a global organization + Experience in biomedical research, scientific analysis and writing + Influential leader who builds… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in people management.** + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will...interpretation of safety data in support of safety update regulatory submissions, investigational and new drug… more
- Ascendis Pharma (Palo Alto, CA)
- …in Palo Alto, California. The team is known for relentlessly delivering to our drug safety internal customers and utilizing the latest trends in technology to ... related systems. + Experience from key technical areas, such as: Argus safety solutions, Argus Analytics, Pharmacovigilance Systems, Argus Product Configuration,… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- Job Title Pharmacovigilance Intern Requisition JR000014766 Pharmacovigilance Intern (Open) Location Webster Groves, MO Additional Locations Job Description ... the real-world experience you are seeking. Summary + The Pharmacovigilance (PV) Summer Intern will assist in the functions...post-marketing adverse event filings to the US Food and Drug Administration received globally. The PV Summer Intern will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or + RN degree preferred **Experience Qualifications** + 4 or More Years drug safety experience with technical experience in Electronic Data Capture and ... industry experience in one or more of the following areas: Drug Safety , Epidemiology, and Clinical Development preferred Daiichi Sankyo, Inc. is an… more
- Sanofi Group (Bridgewater, NJ)
- …Audit and/or specific supplier audits, assessments, or evaluations. + Knowledge of pharmacovigilance , drug safety , or regulatory compliance requirements. + ... Experience with contract negotiation and management. **Languages** + Fluent in English **Job type** + Permanent & Full time **Why Choose Us** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Patient Safety within Gilead; Identifies and leverages advances in pharmacovigilance where appropriate, such as use of artificial intelligence, real-world data, ... **Capabilities & Requirements:** + Prior global leadership experience in a Patient Safety / Pharmacovigilance organization and broad R&D global functional… more
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