Director, Pharmacovigilance Operations

Beeline Medicines•Boston, MA

2d•Hybrid

About The Position

The Director, Pharmacovigilance Operations is responsible for leading the operational infrastructure and execution of the company's global pharmacovigilance (PV) program, ensuring full compliance with applicable safety reporting regulations and internal safety standards. This role oversees the PV operational processes, systems, vendor relationships, and quality frameworks that support individual case safety report (ICSR) processing, expedited and periodic reporting, and inspection readiness activities. The Director partners with the VP/Head of Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs, and external CRO/safety vendors to build and sustain a compliant, scalable PV function within a growing I&I biotech.

Requirements

Bachelor's degree in life sciences, nursing, pharmacy, or a related field required
Minimum of 10+ years of pharmacovigilance experience in the pharmaceutical or biotech industry
5 years in a PV operations leadership role.
Comprehensive knowledge of global pharmacovigilance regulations, including FDA 21 CFR Parts 312 and 314, EU GVP Modules, ICH E2A–E2F guidelines, and EMA/FDA reporting requirements.
Extensive experience managing ICSR processing, expedited reporting, and periodic aggregate report preparation (DSUR, PSUR/PBRER, PADER) in a global PV environment.
Hands-on experience with pharmacovigilance safety databases, including Argus Safety, ARISg, or similar platforms, including system validation and data quality oversight.
Proven track record managing PV vendor relationships, safety data exchange agreements (SDEAs), and co-development or licensing partner PV obligations.
Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
Adept at facilitating productive dialogue in high-stakes meetings, negotiations, and multi-party collaborations; balances clarity, diplomacy, and scientific precision.
Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive decision-making.

Nice To Haves

advanced degree (PharmD, or MS) preferred

Responsibilities

Lead Pharmacovigilance Operations, overseeing all aspects of global ICSR intake, processing, case narrative development, medical coding, and expedited reporting within regulatory timeframes.
Ensure timely and accurate submission of Individual Case Safety Reports (ICSRs) to global Health Authorities, including FDA MedWatch, EudraVigilance, and applicable national pharmacovigilance centers.
Oversee the preparation and submission of periodic safety reports, including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), and Periodic Benefit-Risk Evaluation Reports (PBRERs/PSURs).
Lead the development, maintenance, and continuous improvement of PV SOPs, work instructions, and operational processes in alignment with ICH E2A-E2F guidelines and applicable regulatory requirements.
Manage the pharmacovigilance safety database and associated technology systems, overseeing validation, data quality, and operational compliance (e.g., Argus, ARISg, or equivalent).
Oversee PV vendor relationships, including contract safety organizations (CSOs) and affiliate partners supporting ICSR processing, medical review, and aggregate reporting functions.
Maintain the company's global PV infrastructure, including PV agreements with licensing partners, co-development collaborators, and business partners.
Ensure PV inspection readiness, including internal audit preparation, mock inspections, CAPA development, and regulatory inspection support.
Serve as the operational lead for the company's safety data exchange agreements (SDEAs) and signal detection operational processes in collaboration with PV Scientists.
Contribute to Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and safety labeling updates from an operational execution perspective.
Perform other duties and responsibilities as assigned