Recent Placement – Pharmacovigilance Operations Manager

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Compass Recently Placed a Pharmacovigilance Operations Manager

Compass recently placed a Pharmacovigilance Operations Manager with a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world’s leading biotech companies, with multiple products on the market and a promising development pipeline.

Role Responsibilities Include:

  • Develop local Pharmacovigilance Operations strategy for safety-related organized data collection in clinical trials and commercial activities (eg patient support programs and market research) in compliance with regulatory requirements and Amgen policies and standards
  • Ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across US commercial programs for all products
  • Create local PV Operations safety data collection strategy across clinical trial and commercial programs in line with regulatory requirements and business needs
  • Support Local Safety Officer as point-of-contact in the US for commercial programs executive leadership and working teams for market research and patient support programs
  • Responsible for tracking compliance and execution of Safety reporting requirements in US commercial programs
  • Liaise with Commercial Programs Quality Oversight Team to assist with action plans and remediation activities related to safety reporting in commercial programs
  • Support cross-functional training of US staff and vendors regarding the details of safety reporting requirements in the US
  • Ensure US local variations are addressed in adhering to global requirements for safety reporting; liaise with Healthcare Compliance, R&D Compliance, Quality, Law
  • Facilitate actions between US commercial leads and Safety to implement corrective and preventative actions resulting from monitoring visits, audits and other activities
  • Support US strategic single point-of-contact from Patient Global Safety for commercial programs executive leadership and working teams to support appropriate safety data collection
  • Support guidance and oversight of Safety reporting in US commercial programs
  • Ensure US local variations are addressed in adhering to global requirements for safety reporting; liaise with Healthcare Compliance, R&D Compliance, Quality, Law
  • Facilitate actions between US commercial leads and Safety to implement corrective and preventative actions resulting from monitoring visits, audits and other activities
  • Assist with cross-functional training of US staff and vendors regarding the details of safety reporting requirements in the US
  • Responsible for developing and supporting strong cross-functional relationships and communication
  • Develop and communicate plans/objectives to others
  • Maintain knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods
  • Support the development and implementation of new processes and methods within and across Global Patient Safety
  • Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
  • Assist with maintenance and implementation of functional curriculum
  • Provide input to GRAAS contracting groups globally
  • Support training within functional area, and as applicable for other functions and vendors
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
  • Develop meaningful team goals in alignment with department goals
  • Assist the leadership team to build an organization and processes that will support future department, company and industry challenges

 

For more information on qualified candidates or job openings please contact us at (925) 884 – 3811 or Requests@CompassCGroup.com

 

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