- US Tech Solutions (Madison, NJ)
- …Sciences, Information, or similar background (Bachelors, Masters) * 5+ years Drug Safety/ Pharmacovigilance experience * Advanced Tableau, Spotfire, Power BI, ... **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)
- …Sciences, etc.) or equivalent experience required. + 7+ years of experience in pharmacovigilance / drug safety, with 3+ years in a compliance, oversight, or ... 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 role is… more
- Taiho Oncology (Princeton, NJ)
- …responsible compounds, as well as regulatory guidelines as they pertain to drug safety/ pharmacovigilance . + Responsible for Individual Case Safety Report (ICSR) ... and Abilities: + Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial experience in managing adverse event and SAE… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …professional management experience in PV required - 10+ years of Drug Safety/ Pharmacovigilance experience, including both investigational and marketed products ... AE reporting language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees… more
- System One (Jersey City, NJ)
- …Project Management is responsible for providing support to regional and global Drug Safety Pharmacovigilance (PV) projects. Projects include global marketing ... 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 with ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- ThermoFisher Scientific (Greenville, NC)
- …of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance / drug safety (global experience is a plus) + At least 1 ... instructions, forms, templates) + Support adverse event reporting training and pharmacovigilance awareness activities cross functionally + Support the preparation of… 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 team ... 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 (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. **Global Pharmacovigilance (PV) Senior Scientist, Obesity - US Remote** **Live** **What you will do** ... guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO...**Basic Qualifications:** Doctorate degree and 2 years of safety/ pharmacovigilance experience OR Master's degree and 4 years of… more
- Takeda Pharmaceuticals (Boston, MA)
- …**About the role:** Join Takeda as an Executive Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical safety ... of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, Therapeutic Area… more
- Ascendis Pharma (Palo Alto, CA)
- …join Ascendis Pharma as our new Technical Business Analyst for the Pharmacovigilance IT team. Ascendis Pharma is a fast-growing biopharmaceutical company with ... of patients, science, and passion, we use our TransCon(R) drug development platform to fulfill our mission of developing...you will play a crucial role in digitalizing our pharmacovigilance team as we embark on an ambitions journey… more
- Takeda Pharmaceuticals (Boston, MA)
- …Medical Review and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory requirements worldwide + Provides a robust, patient-centered, ... Benefit Risk, and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory requirements worldwide + Supports and advocates the...evaluation of risk) as an integral part of the drug development and marketing continuum. + Act as an… more
- Takeda Pharmaceuticals (Boston, MA)
- …from Orbit to MEDIEVA. **Internship Development Opportunities:** + Understanding Pharmacovigilance : Interns will learn about the processes and regulations involved ... in drug safety and monitoring adverse effects. + Regulatory Knowledge:...knowledge of international regulations and compliance requirements related to drug safety. + Collaboration and Communication: Gain experience in… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Procedures + 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
- 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 Safety ... pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred Daiichi Sankyo, Inc. is an… more
- CSL Behring (King Of Prussia, PA)
- …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 relationships… more
- Nestle (Brisbane, CA)
- …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 operations.… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Proven track record of leadership and strategic management, team development in pharmacovigilance . + Strong understanding of drug development processes and ... President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the assigned portfolio. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities. Oversee and ensure ... of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU… more
- Boehringer Ingelheim (Ridgefield, CT)
- …investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Continuous ... of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU… more
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