Manager – Pharmacovigilance Operations

At least 3 – 5 years’ experience in PV Operations
Bachelor’s degree in life sciences or nursing
Experience with safety databases (ARGUS, ARISg, and/or Veeva) required
Good knowledge of FDA and EMA regulations required
Critical thinking, proactive and keen attention to detail
Be able to work well independently as well as a team player
Strong work ethic and interpersonal communication
Positive attitude and enthusiasm to adapt to changing timelines and deliverables

Serve as the PV operations lead for the assigned studies and be responsible for managing and completing all PV deliverables for those studies
Partner with the Tango regulatory operations team and be the primary point of contact for tracking all submissions of expedited reports, ensuring high compliance with regulatory timelines
Be involved in analyzing safety data from an operations perspective to make sure that the PV processes are performed in a consistent and compliant manner across all Tango programs
Participate in the review of study plans, including protocols, safety management plans, CRF completion guidelines, data validation manuals, and take part in the necessary UAT testing for EDC modifications
Manage the review of PV documentation in the TMF, and report any findings to the TMF lead in Clinical Quality and Compliance
Assist with monitoring internal drug safety mailbox, and triage communications with the appropriate colleagues to ensure timely action
Participate in a routine assessment of vendor performance and apply your expertise/experience in making recommendations for improvement to any identified gaps
Support any other ad-hoc projects as needed