- 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
- Rhythm Pharmaceuticals (Boston, MA)
- …+ Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents ... providers and cross functional internal teams, including clinical, medical, pharmacovigilance and regulatory + In collaboration with Procurement, responsibilities… more
- BeOne Medicines (San Mateo, 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
- Ascendis Pharma (Princeton, NJ)
- …+ Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations ... the products are reflected accurately. + Collaborates with, and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives. +… 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation… more
- Taiho Oncology (FL)
- …Respond to unsolicited medical information requests in the field. + Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related ... to medical inquiries and drug safety information. + Use medical affairs plans to develop and align the tactical plan for Sr. Manager, Medical Field geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned… more
- Bristol Myers Squibb (San Diego, CA)
- …provide key scientific updates to internal stakeholders (eg Commercial, Regulatory, Pharmacovigilance , Legal, HEOR, Value Access & Payment) + Provide scientific ... agreed upon with home office medical and GDO + Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies,… more