Director, Pharmacovigilance Operations

About Beeline Medicines:

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

Job Summary:

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.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and 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

Qualifications:

• Education: Bachelor's degree in life sciences, nursing, pharmacy, or a related field required; advanced degree (PharmD, or MS) preferred


• 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.

Benefits:

We offer a comprehensive benefits package including:

• Medical, Dental & Vision insurance (employee premiums 100% covered by company)


• 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge


• Flexible work arrangements / hybrid schedule


• Health Savings Account (HSA)

*Benefits are subject to eligibility requirements and plan terms. Additional details provided during the offer process*

Equal Employment Opportunity:

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation:

If you require a reasonable accommodation to participate in the application or interview process, please contact [email protected] to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines