Associate Director, Pharmacovigilance Operations

COMPANY INTRODUCTION

Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.

SUMMARY

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.

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.

EXPERIENCE & QUALIFICATIONS

• Bachelor’s 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

The posted range reflects the current reasonable and good faith estimate of the base salary for this full-time position. Actual compensation will be based on a variety of factors including, but not limited to, relevant skills and experience, educational background and certifications, performance and qualifications, market demand for the role, geographic location and other organizational needs. This role also offers a competitive target bonus, equity, and a comprehensive benefits package.

We are committed to fair pay practices, and we regularly review our compensation programs to ensure they are competitive, equitable, and aligned with our values. Please note that the advertised pay range is not a guarantee or promise of a specific wage.

Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio or @hire.lever.co. Please disregard any other communications that do not originate from these domain names. If you receive any suspicious requests or communications, please verify their authenticity before responding.