Pharmacovigilance Operations Manager

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Pharmacovigilance Operations Manager

Cambridge, Massachusetts

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Full Time

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NA

Cambridge, Massachusetts

Full Time

NA

January 18, 2023

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Job ID: P1321292BOSAC_1674083812

January 18, 2023

Job ID: P1321292BOSAC_1674083812

Job Summary

Job Id: P1321292BOSAC_1674083812 Apply Now

Position Summary: As a team member of the DSPV organization, the Pharmacovigilance Operations Manager will provide functional support to Safety database implementation project through a PV vendor (on-going), oversight on safety data migration from current clinical trial vendors (on-going), manage ICSR case processing through new PV vendor, other Pharmacovigilance (PV) operational activities assigned by the functional head.

The PV operations manager will work closely with the Pharmacovigilance team, Clinical Operations team, Regulatory affairs team, Quality organization and cross-functional teams for clinical development programs.

This role requires accountability and sense of urgency in a complex work environment including strong project management, written and verbal communication skills. The incumbent will have the following responsibilities including but not limited to:

  • Manage PV vendor that will host and perform ICSR case processing.
  • Manage day to day activities associated with ICSR case processing (sponsor medical review, regulatory reporting, reconciliations etc.)
  • Authors and/or reviews section of key PV CRO documents as they relate to safety database and case processing (Safety Management Plan, Medical Monitoring Plan, SAE Reporting, Communications plan, etc)
  • Collaborate with PV vendor, clinical studies vendor(s) and regulatory operations to ensure quality and compliance for safety reporting (e.g., KPI)
  • Oversight on alliance management related to safety (e.g., safety data exchange agreements, cross-reporting)
  • Develop, contribute, review, and maintain up to date safety case processing SOPs, forms etc.
  • Liaise with cross-functional teams for timely communication/dissemination of safety deliverables
  • Support GCP/GVP audits and inspections
  • Collaborate with Quality organization and lead DSPV contributions for audit and inspections
  • Manage DSPV departments meetings, budget and other operational activities assigned by the functional head.

Minimum Basic Qualifications:

  • Medical Sciences qualifications: Pharmacy degree, Nursing degree or MS in health-related field.
  • At least 10 years of experience in biotech/pharma/CRO with at least 5 years in PV operations.
  • Advanced management/business degree (MBA, PM) desired.
  • In depth understanding of safety database (Argus), reporting requirements and medical terminology
  • In depth knowledge of global safety regulations, guidances, and processes
  • Must be detail-oriented and must have strong project management, organizational and communication skills
  • Experience in managing PV vendors and developing PV SOPs
P1321292BOSAC_1674083812

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

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