Pharmacovigilance Operations Manager

Job Description

Job Description

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). 

Position Summary:

The Pharmacovigilance Operations Manager will support the Pharmacovigilance Department by contributing to the execution, maintenance, and continuous improvement of pharmacovigilance processes, systems, compliance activities, and operational oversight.

This individual contributor role serves as a subject matter expert within Drug Safety and will partner closely with internal stakeholders and external pharmacovigilance vendors to support high-quality safety case processing, regulatory reporting, compliance monitoring, and operational excellence. The successful candidate will demonstrate strong pharmacovigilance expertise, sound judgment, and the ability to manage multiple priorities while working independently in a fast-paced environment.

This position requires a collaborative professional who can effectively influence cross-functional partners, identify process improvement opportunities, and ensure pharmacovigilance activities are executed in accordance with applicable regulations, guidelines, and company procedures.

• Serve as a key contributor supporting pharmacovigilance operational and case management activities for safety data processing and reporting in accordance with applicable regulations and company procedures.

• Coordinate SAE and SUSAR reporting activities for Vericel's investigational and marketed products.

• Support oversight of pharmacovigilance vendors through performance monitoring, quality reviews, and issue escalation as appropriate.

• Develop, maintain, and monitor key performance indicators (KPIs) and operational metrics to support vendor oversight and compliance activities.

• Contribute to signal management activities and the preparation of periodic and aggregate safety reports.

• Coordinate SAE reconciliation activities with internal and external stakeholders.

• Contribute to safety sections of regulatory submissions and other regulatory documents, as assigned.

• Support the management, maintenance, and continuous improvement of pharmacovigilance operational documents, including SOPs, work instructions, and process documentation.

• Draft, revise, and maintain departmental procedures and associated documentation.

• Participate in internal and external training activities related to pharmacovigilance processes and compliance requirements.

• Support regulatory inspections, audits, and inspection readiness activities.

• Maintain knowledge of Safety Data Exchange Agreements (SDEAs), pharmacovigilance agreements, and applicable regulatory requirements.

• Identify opportunities to improve pharmacovigilance processes, quality, efficiency, and compliance.

• Partner effectively with Regulatory Affairs, Clinical Operations, Quality, Medical Affairs, and external vendors to support pharmacovigilance objectives.

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Additional responsibilities may be assigned based on business needs.

• Bachelor's degree or advanced degree in life sciences, nursing, pharmacy, or a related healthcare discipline.

• Minimum of 7 years of relevant industry experience, including at least 5 years of pharmacovigilance experience supporting clinical and post-marketing products.

• Experience supporting pharmacovigilance operations, case processing, regulatory reporting, and vendor oversight activities.

• Experience with Argus Safety databases, EDC systems, and electronic document management systems.

• Experience supporting pharmacovigilance activities for combination products and/or medical devices preferred.

• Working knowledge of GCPs, GVPs, ICH guidelines, FDA regulations, and global pharmacovigilance requirements.

• Proficiency with MedDRA and WHO Drug dictionaries.

• Demonstrated ability to independently manage multiple priorities and deliver high-quality work with minimal supervision.

• Strong analytical, organizational, and problem-solving skills.

• Excellent communication and collaboration skills with the ability to work effectively across functions.

• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $109,000 to $158,000 annually.

The actual title and salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

EEO Statement
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.