Hybrid Product Safety & Pharmacovigilance Manager

Posted 4 days ago

Apply now

About the role

  • Manage activities of CROs, vendors, and temporary staff performing PV operations.
  • Oversee and guide case processing activities to ensure effective monitoring and evaluation of product safety information.
  • Oversee PV system to ensure compliance of employees, partners and distributors.
  • Maintain safety databases (e.g., Argus, ArisG) and ensure data accuracy and compliance.
  • Ensure ongoing maintenance and revision of PSPV Standard Operating Procedures, Work Instructions, and Job Aids.
  • Ensure PV operation continuity including maintenance of process or disaster recovery plan of Safety Database.
  • Supervise and manage preparation and submission of aggregate reporting in accordance with applicable regulations.
  • Maintain training matrix in PSPV team and lead trainings of PSPV members or new hires.
  • Oversee preparation and execution of deviation reports, note to files and Corrective and Preventive Actions (CAPAs).
  • Manage pharmacovigilance agreements or safety clause in contracts with partners or CROs.
  • Act as the responsible contact person for safety-related aspects and PV.

Requirements

  • Bachelor’s degree in pharmacy or nursing (BSN/RN) required.
  • Minimum of 5 years in Drug Safety/Pharmacovigilance in the pharmaceutical industry.
  • Previous experience with safety database programs; i.e., Argus, Aris-G, etc. desired.
  • Applied knowledge of global regulations and global compliance timelines desired.
  • Demonstrated computer experience with MS Word, Excel, Access and Outlook.
  • Excellent written and verbal communication skills, organizational skills and attention to detail.
  • Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team.
  • Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
  • Highly analytical with the ability to give attention to detail.
  • Capable of troubleshooting and managing multiple projects simultaneously.

Benefits

  • Health insurance
  • Paid time off
  • Professional development opportunities
  • Flexible working arrangements

Job title

Product Safety & Pharmacovigilance Manager

Job type

Experience level

Mid levelSenior

Salary

$130,000 - $150,000 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job