- Merck (Rahway, NJ)
- …of business partner and vendor PV agreements and leadership of the Global Clinical Safety & Pharmacovigilance (GCS&PV) implementation activities for partner ... work with all levels of management within and outside of Global Regulatory Affairs and Clinical Safety (GRACS). + Interact closely with the system owner for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …product maintenance and lifecycle management. + Represent all activities related to pharmacovigilance , clinical safety , risk management and signal detection, ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Associate Director, Global Patient Safety Signal Management and Innovation in… 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
- System One (Basking Ridge, NJ)
- Associate Director, Clinical Safety ...+ international MD is okay + 1-3 years of Pharmacovigilance (PV)/ clinical safety experience in ... component of the B/R assessment. Skills : + 1-3 years of Pharmacovigilance (PV)/ clinical safety experience in pharmaceutical drugs either from relevant work… more
- BeiGene (Emeryville, CA)
- **General Description:** _The Associate Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... Clinical Trial Support** + Lead the review of safety data and monitor the safety of...**Supervisory Responsibilities:** This position has no direct reports. The Associate Director, Safety Scientist is part of… more
- Pfizer (Tampa, FL)
- …candidate will be an active contributor to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer's ... **POSITION PURPOSE** Pfizer's US Drug Safety Unit (DSU) is excited to announce an...life sciences required + Minimum 5 years' experience in pharmacovigilance and/or data management, clinical care, or… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title** : Associate Director, Clinical Quality Compliance **Location** : Cambridge, MA **About the ... role:** As the Associate Director, Clinical Quality Compliance, you will...and compliance governance in Takeda, including the and the Clinical & Safety Quality Council, communicating any… more
- BeiGene (San Mateo, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, ... **General Description:** The Associate Director - Clinical Science will...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports. + Clinical sections of… more
- AbbVie (North Chicago, IL)
- …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… more
- AbbVie (North Chicago, IL)
- …pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for ... to regulatory responses and discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to… more
- AbbVie (Chicago, IL)
- …(Bachelors candidates) OR 2+ years of clinical /pharma or safety work experience (Masters/Doctorate candidates) + Pharmacovigilance experience Other ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director - Safety Data Sciences (Remote)...or more assigned compounds and products) through review of safety data from clinical trials, safety… 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...PV Operations, is responsible for all assigned Ascendis Drug Safety PV Operations related activities for all products in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …physicians in the global CNS, Retinopathy and Emerging Areas Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of ... PADERs + Development Safety Update Reports + Risk Management Plans + Clinical Overview Statements + Continuous monitoring and further development of the product … more
- Takeda Pharmaceuticals (Columbus, OH)
- …Serves as the strategic Quality thought partner to Procurement and relevant clinical , pharmacovigilance and medical functions responsible for the engagement and ... of Takeda's strategic suppliers who are engaged to provide/conduct regulated clinical , pharmacovigilance and medical services and/or activities. + Ensures… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director, Safety Scientist in Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical ... relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.… 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 ...years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years). + Medical… more
- AbbVie (North Chicago, IL)
- …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
- AbbVie (North Chicago, IL)
- …pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for ... submissions and responses and other program documents. + May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same… more
- AbbVie (Jersey City, NJ)
- …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. Experts on… more
- Takeda Pharmaceuticals (Boston, MA)
- …improvement + Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice ... metrics for CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the… more