- Novo Nordisk (Plainsboro, NJ)
- …in relation to Pharmacovigilance ( PV ) oversight. This role fulfills the PV Oversight function in PV quality control processes, as well as ... ie team members. Relationships Reports to head of NAO Quality PV Oversight Vendor Assessment Team and... control on identified areas of focus within external pharmacovigilance ( PV ) partners + Responsible for the… more
- Novo Nordisk (Plainsboro, NJ)
- …understandable manner to ie team members. Relationships Reports to head of NAO Quality PV Oversight. Maintains positive rapport and working relationships within ... and in a manner which meets their expectations + Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering… more
- Ascendis Pharma (Palo Alto, CA)
- …appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Contribute to the maintenance ... the assigned Vendor Management activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and… more
- Ascendis Pharma (Palo Alto, CA)
- …appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits. . Functions as a patient ... to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff. . Provides pharmacovigilance expertise to Ascendis or… more
- AbbVie (North Chicago, IL)
- …industry or with a regulatory authority . 5 - 7 years of experience in Quality Assurance and/or Pharmacovigilance An equivalent combination of education and ... development and implementation of systems and processes required to support global quality assurance requirements. . Contributes to development and continuous… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance ( PV ) operations. + **Audit Management:** Oversee the planning, ... Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes. +...human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial… more
- Takeda Pharmaceuticals (Boston, MA)
- …issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance , Medical Affairs, Marketing, Manufacturing, and Legal. + ... in full compliance to worldwide regulations. + Train and mentor Pharmacovigilance Physicians and Specialists. + Maintain professional knowledge and accreditation by… more