- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) and/or ... with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance , Regulatory Affairs, Global Medical and Scientific Affairs to align on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and External Vendors for the data services they provide to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and ... safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and pre-launch planning for pipeline assets. Relationships Reports to Associate Director/Director, Strategic Market Insights. Supports current assets, future ... MR process RFP, proposal, agency selection, SOW submission, contracting, Pharmacovigilance and compliance requirements, PO generation, execution of qualitative and… more
- Boehringer Ingelheim (Athens, GA)
- **Description** The AD Global PV Data Analysis supports the Global Pharmacovigilance (PV) team to ensure compliance with all regulations and laws worldwide on ... Pharmacovigilance (including but not limited to FDA 21 CFR,...data internally as to the Health authorities. + Providing Pharmacovigilance Information (RPI) as requested to other departments within… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance ... Grifols pharmaceutical products. + Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description Purpose: Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: + Understanding… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in the ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of... Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment… more
- BeiGene (San Mateo, CA)
- …evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and ... Contribute to integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist in… more
- Bristol Myers Squibb (Princeton, NJ)
- …medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety ... documents for new and expanded indications (Filing Activities). Ensures pharmacovigilance regulatory compliance. Mentors less experienced scientists and teams in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of physicians in the global Inflammation Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. ... investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Periodic Benefit… more
- Lilly (Indianapolis, IN)
- …and volunteerism. **Purpose:** The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise working ... areas relevant to drug discovery or development, eg epidemiology, toxicology, pharmacovigilance , regulatory affairs + Experience within Global Patient Safety or… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director, External Research, Scientific Affairs provides strong subject matter expertise, operational oversight and process requirement ... Protocol + Leads and works cross functionally with Global Pharmacovigilance , CDMA TA Medical, and RA to review the...to the terms of the trial agreement and the pharmacovigilance agreement as they relate to the safe use… more
- Boehringer Ingelheim (Ridgefield, CT)
- …team of physicians in the global CREA Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. This ... investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Periodic Benefit… more
- Merck (Columbus, OH)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT,… more
- Bristol Myers Squibb (Chicago, IL)
- …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 **Fundamental to the Role: Compliance** + Understands and adheres to the BMS Standards of Business Conduct and Ethics, all Company policies and… more
- Randstad US (Cambridge, MA)
- senior safety associate iii. + cambridge , massachusetts + posted 1 day ago **job details** summary + $50.72 - $57.58 per hour + contract + bachelor degree + ... hour work hours: 9 to 5 education: Bachelors responsibilities: The Senior Safety Associate III will be responsible for supporting Global Case Management with ICSR… more
- Merck (Columbus, OH)
- **Job Description** **Position Description:** ** Associate Clinical Research Manager (aCRM) - Oncology** With support of other Clinical Research Manager's (CRMs) ... with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance , Regulatory Affairs, Global Medical and Scientific Affairs to align on… more
- Bristol Myers Squibb (Washington, DC)
- …data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on managing a team ... Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing… more
