- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …is preferred (MS, Pharm.D.) + At least one year of relevant experience in pharmacovigilance , clinical research, or regulatory affairs in a CRO or a ... guidelines + Expertise in therapeutic products and areas; medical coding; safety -data administration + Pharmacovigilance Specialist should possess autonomy and… more
- Amgen (Washington, DC)
- … safety / pharmacovigilance experience OR Bachelor's degree and 6 years of safety / pharmacovigilance experience OR Associate degree and 10 safety / ... product life-cycles. **Key responsibilities:** + Support and provide oversight with regards to safety in clinical trials by providing inputs on study protocols,… more
- AbbVie (North Chicago, IL)
- …reports (PSUR's, PADER's etc.) + Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing. + ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: +… more
- Amgen (Washington, DC)
- … safety / pharmacovigilance experience OR Bachelor's degree and 6 years of safety / pharmacovigilance experience OR Associate 's degree and 10 years of ... for and compliance issues are completed documents + Participate as liaison between clinical trial and Global Patient Safety to ensure capture of all… more
- Insight Global (Florham Park, NJ)
- Job Description Insight Global is looking for a Pharmacovigilance Associate for one of our clients to sit in Florham Park, NJ. They focus within women's health ... workload due to a new study which requires drug safety and a new approved drug product acquisition. This...directly with CROs, review of ICSR, and any other clinical study documentation. We are a company committed to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing ... + Safety issue management + Set-up of safety analyses in both post marketing and clinical...as appropriate + Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance… more
- Taiho Oncology (Princeton, NJ)
- …collaboration with team members. + Maintain training and oversight to clinical operations/ pharmacovigilance vendors supporting pharmacovigilance activities, ... Associate Director, PV Sciences Pleasanton, CA, USA *...and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other… more
- BeiGene (San Mateo, CA)
- …safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions._ ... Clinical Trial** **Support** + Lead the review of safety data and monitor the safety of...**Supervisory** **Responsibilities:** The position has no direct reports. The Associate Director, Safety Scientist is part of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and expert team of physicians in the global Inflammation Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our ... PADERs + Development Safety Update Reports + Risk Management Plans + Clinical Overview Statements + Continuous monitoring and further development of the product … more
- Novo Nordisk (Plainsboro, NJ)
- …for Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance as well as Safety training conducted for internal and external ... information for all Novo Nordisk products. Relationships Reports to Associate Director - Patient Safety - Training....database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice… more
- Lilly (Indianapolis, IN)
- …volunteerism. **Purpose:** The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise ... pharmacovigilance , regulatory affairs + Experience within Global Patient Safety or demonstrated knowledge and understanding of pharmacovigilance ,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …motivated and expert team of physicians in the global CREA Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our ... PADERs + Development Safety Update Reports + Risk Management Plans + Clinical Overview Statements + Continuous monitoring and further development of the product … more
- Ascendis Pharma (Palo Alto, CA)
- …drug safety required. + Minimum of 8 years recent experience in Pharmacovigilance required + Expert knowledge of FDA safety regulations, ICH Guidelines, and ... The Associate Director Global PV Operations reports directly to the Sr Director, Medical Safety Science-Oncology. Under the direction of the Sr Director, Medical… more
- Randstad US (Cambridge, MA)
- senior safety associate iii. + cambridge , massachusetts + posted april 26, 2024 **job details** summary + $50.72 - $57.58 per hour + contract + bachelor degree ... hours: 9 to 5 education: Bachelors responsibilities: The Senior Safety Associate III will be responsible for...Case Processing (data entry and quality review) of both Clinical Trial and Post-marketing ICSRs + Advanced proficiency in… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director, External Research, Scientific Affairs provides strong subject matter expertise, operational oversight and process requirement ... and external connections to work with Corporate and Local Clinical Development and Medical Affairs (CDMA), Legal and other...Protocol + Leads and works cross functionally with Global Pharmacovigilance , CDMA TA Medical, and RA to review the… more
- Sanofi Group (Cambridge, MA)
- …at the investigator meetings + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety , stat outputs of blinded data, ) ... study report + Take on as necessary the Associate CRD role: + Develop the abbreviated protocol +...Clinical Scientists, Medical review team and Coding + Pharmacovigilance (GSO, CME) + CTOMs, Biostatisticians + CSU medical… more
- Merck (North Wales, PA)
- **Job Description** Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through ... clinical trials and surveillance, we ensure the ...products to produce safe, effective, innovative medicine. The Global Clinical Data Standards Vocabulary Specialist, Associate Director,… more
- AbbVie (Irvine, CA)
- …pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for ... and responses, and other program documents. + May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on… more
- ThermoFisher Scientific (Greenville, NC)
- …are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client ... ensure that the medical content is accurate and complete. ** Clinical Trial Support:** + Monitors all safety ...1-2 years) in the industry. + Direct experience in safety / Pharmacovigilance (comparable to 2 years). + Candidates… more
- ThermoFisher Scientific (Wilmington, NC)
- …are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client ... is accurate and complete. + Contributes to departmental process improvement initiatives. Clinical Trial Support: + Monitors all safety variables (AE, laboratory… more