Associate Director, Pharmacovigilance Operations

Triveni Bio•Watertown, MA

3d•$185,000 - $200,000

About The Position

Triveni Bio is seeking an Associate Director, Pharmacovigilance Operations to serve as the first in-house PV subject matter expert for the company. Reporting to the VP, Clinical Development, you will execute in-house safety operations and ensure these are aligned with company standards and regulatory requirements. You will partner closely with Clinical Operations, Regulatory Affairs, Clinical Development, Quality, and Data Management, as well as external vendors and CROs, as applicable, to ensure robust safety oversight throughout drug development. The successful candidate will bring operational execution strength, supporting a strong focus on quality, compliance, and continuous improvement. We operate in a highly collaborative and lean environment, where individuals are encouraged to contribute beyond their core function. This role is ideal for someone who is energized by working with others in service of the patients we aim to serve and is eager to stretch outside their comfort zone.

Requirements

Bachelorâs degree in life sciences or related field (advanced degree preferred)
8+ years of experience in pharmacovigilance within biotech, pharma, or a CRO environment
Direct experience managing PV operations for clinical-stage products
Strong working knowledge of global PV regulations and guidelines (FDA, EMA, ICH, GCP, GVP)
Experience managing safety databases
Proven ability to work independently and operate effectively in a lean, fast-paced environment

Responsibilities

Oversee ongoing safety surveillance activities, in collaboration with relevant cross functional team members, including safety data review and signal evaluation.
Lead aggregate report (eg DSUR) activities.
Oversee timely collection, analysis, and reporting of adverse events, including responsibility for end-to-end case processing activities.
Prepare materials, as needed, for safety governance meetings.
Contribute to and coordinate preparation and review of regulatory submissions from a safety perspective and coordinate responses to ad hoc safety queries in collaboration with relevant cross functional team members.
Collaborate with relevant PV vendors (e.g., CROs, safety databases, medical monitoring partners), as appropriate, ensuring timely delivery and compliance with contractual obligations
Ensure accurate data flow and reconciliation between safety, clinical, and regulatory systems.
Ensure PV activities are compliant with global regulatory requirements (FDA, EMA, ICH, GCP, GVP), etc).
Collaborate with Quality to support audits, inspections, and corrective actions related to PV processes.
Develop and maintain PV SOPs, workflows, and documentation appropriate for a growing biotech organization.
Design, in collaboration with relevant cross functional partners, scalable processes that evolve with pipeline expansion and later-stage development. Contribute to safety content in protocol development, IBs, informed consent forms, clinical study reports and relevant study documents (eg Safety Management Plan).
Perform ongoing data reviews, including labs, vitals, ECGs, and AEs, for ongoing clinical trials.
Act as a trusted advisor to internal stakeholders on safety-related matters.
Maintain strong working knowledge of relevant regulations.