Director, PV Operations

Bicara Therapeutics•Boston, MA

1d•Hybrid

About The Position

The Director of Pharmacovigilance (PV) Operations will provide strategic and operational leadership for pharmacovigilance activities across the clinical development lifecycle, with readiness to support future post-marketing activities. This role is responsible for ensuring compliant, efficient, and high-quality safety operations in accordance with global regulatory requirements, while partnering closely with cross-functional stakeholders in a fast-paced oncology biotech environment. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field required; advanced degree (MS, PharmD, PhD) preferred.
Minimum of 8+ years of experience in pharmacovigilance within the biopharmaceutical industry.
At least 3+ years of leadership or management experience overseeing PV operations and/or vendors.
Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH).
Hands-on experience with safety databases, case processing, and regulatory safety reporting.
Excellent communication, leadership, and cross-functional collaboration skills.
Ability to operate independently and strategically in a small, evolving organization.

Nice To Haves

Prior experience in oncology or related therapeutic areas.
Experience supporting early- to mid-stage clinical development programs in a biotech setting.
Experience building or scaling PV operational processes in a growing organization.

Responsibilities

Lead and oversee all PV operational activities, including adverse event intake, case processing, quality review, and regulatory reporting.
Ensure timely and compliant submission of expedited safety reports (e.g., SAEs, SUSARs) and support aggregate safety reporting activities (e.g., DSURs, PSURs/PBRERs).
Manage PV vendor relationships, including case processing and safety database vendors; establish and monitor KPIs, quality metrics, and service performance.
Oversee the safety database and associated workflows to ensure data integrity, inspection readiness, and regulatory compliance.
Develop, implement, and maintain PV SOPs, work instructions, and operational processes aligned with FDA, EMA, ICH, and global PV regulations.
Serve as the primary PV Operations interface with Clinical Development, Regulatory Affairs, Data Management, Quality, and external partners.
Provide operational input into clinical and regulatory documents, including protocols, Investigator’s Brochures, informed consent forms, and risk management plans.
Support safety governance activities, including Signal Surveillance Team (SST) and Safety Review Team (SRT) meetings.
Lead inspection and audit preparedness activities and support responses to health authority inquiries.
Mentor and develop PV Operations staff and contribute to the growth and scaling of the pharmacovigilance function.