- BeOne Medicines (Emeryville, CA)
- …leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face ... + Leads GPS product co-ordination, chairs product group meetings across GPS ** Pharmacovigilance :** + Leads and manages safety PV processes for BeiGene and competitor… more
- Takeda Pharmaceuticals (Boston, MA)
- …compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by ... and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance -related change controls. + Provides data insights to emerging… more
- Takeda Pharmaceuticals (Boston, MA)
- …development technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. This role is accountable for shaping and ... publishing tools, global submission management, labeling platforms, IDMP readiness). Pharmacovigilance Technologies (safety databases, signal detection, case processing automation,… more
- BeOne Medicines (Emeryville, CA)
- …integrated Benefit/Risk assessments. + Promote and Advance the Field of Pharmacovigilance . + Responsible for effective execution, communication and influence with ... organizational effectiveness and productivity. + Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.… more
- System One (Tarrytown, NY)
- …on experience) Contractor Work Model: Remote Highlights should include: 1. Pharmacovigilance & Aggregate Reporting Expertise + Direct experience authoring or ... Inspection Readiness + Participation in regulatory inspections or audits focused on pharmacovigilance . + Preparation of documentation for FDA, EMA, MHRA, or other… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + Provide strategic ... expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support the… more
- Astrix Technology (Chicago, IL)
- …responses to health authority inquiries. + Stay current with global pharmacovigilance regulations and guidelines to ensure compliance and best practices. ... relevant specialty is preferred. + Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry. + Strong… more
- Takeda Pharmaceuticals (Boston, MA)
- …in full compliance to worldwide regulations. + Train and mentor Pharmacovigilance Physicians and Specialists. + Maintain professional knowledge and accreditation by ... + At least 5 years of experience in pharmaceutical industry within Drug Safety/ Pharmacovigilance , with both investigational and marketed products. + At least 3 years… more
- United Therapeutics (Research Triangle Park, NC)
- …We are seeking an experienced Senior Product Safety Scientist to join our dynamic pharmacovigilance team. You will play a key role in managing the safety profile of ... data from a safety perspective + Intermediate to advanced knowledge of pharmacovigilance processes and regulatory requirements + Advanced knowledge of MedDRA coding… more
- Astellas Pharma (Northbrook, IL)
- …Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV). + Demonstrated success working with key external ... including presenting/responding to health authorities. + Knowledge of global pharmacovigilance standards and guidance documents. Comfortable working in a flexible,… more