- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …drug development process and GxP requirements (ie, clinical studies, post-marketing/ pharmacovigilance , and labs). + Thorough knowledge of standards, systems, ... policies and procedures that enable QMS operations, integrations and compliance within the biopharma GxP environment. + Demonstrates strong strategic and analytical skills, with strengths in assessing complex information and understanding the quality and… more
- AbbVie (North Chicago, IL)
- …key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Medical Doctor (MD) or non-US equivalent of MD degree with relevant therapeutic specialty (Neurology or Psychiatry) Completion of a residency program in Psychiatry or Neurology strongly preferred. + At least 2… more
- Lilly (IN)
- …the therapeutic area. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards ... in conducting research. **Minimum Requirements:** + Expertise in radiopharmaceutical/internal dosimetry using MIRD-based and voxel-based dosimetry software + Demonstrated ability to communicate dosimetry and/or modeling results to a multidisciplinary audience… more
- AbbVie (Irvine, CA)
- …health authority meetings. + Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and to all other quality ... standards in conducting research. Qualifications + Bachelor's degree in the sciences; advanced degree (eg, MS, PhD, PharmD) preferred. + At least 8 years of clinical study experience in pharmaceutical industry, academia, or equivalent. + Ability to run a… more
- Edgewell Personal Care (Allendale, NJ)
- …+ Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and establish effective networks ... across diverse teams at all levels of the organization. + Strong analytical skills. + Strong sense of urgency and ability to continuously reprioritize. + Ability to manage multiple activities simultaneously. + High degree of attention to detail, organization… more
- Ascendis Pharma (Palo Alto, CA)
- …Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for managerial oversight ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… more
- Boehringer Ingelheim (Duluth, GA)
- …questions. All communications will be recorded in the BIAH Pharmacovigilance (PV)Database in compliance with BIAH corporate, Veterinary Technical Solutions ... trend reports or issues involving product usage. + Supports the AD, SAD or Director in projects as assigned. + Participates in the review and implementation of… more
- Takeda Pharmaceuticals (Boston, MA)
- …Category Manager (GCM) - Clinical Development Services Procurement at the Associate Director level, plans and leads category projects for a clearly defined ... or buying of Compliance Services categories, including but not limited to pharmacovigilance services.** You will be assigned to support Takeda's Research &… more
- Boehringer Ingelheim (Ridgefield, CT)
- …area from the regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access and commercial perspective. This role provides ... or Master of Drug Regulatory Affairs, RAC certification preferred **Associate Director Experience Requirements:** + Two (2) years of professional experience in… more