Manager/Sr. Manager, Pharmacovigilance Operations

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:

Manager/Senior Manager, Pharmacovigilance Operations will support the Pharmacovigilance Department. The candidate will assist in development, implementation, and maintenance of a safety quality system for all Drug Safety activities, encompassing processes, procedures, compliance, and metrics. The Manager/Senior manager will oversee pharmacovigilance activities and vendor management for contracted pharmacovigilance vendors. This role requires an experienced manager capable of collaborating with multiple stakeholders to ensure compliance and high-quality standards. The individual must manage multiple tasks and prioritize projects effectively.

Schedule: This position is in-office from Monday - Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays.

Position Scope:

• Take a lead role in supporting oversight of pharmacovigilance operational and case management activities for safety data processing and reporting in accordance with all applicable regulations, guidelines with little or no supervision.
• Coordinate and manage SAE/SUSAR reporting activities for Vericel's investigational and marketed products
• Partner with manager to oversee pharmacovigilance vendor management, performance and quality evaluation.
• Create, track, monitor Key Performance Indicators (KPIs) and metrics for vendor performance monitoring.
• Contribute to signal management activities and preparation of applicable periodic/aggregate safety reports.
• Lead coordination of SAE reconciliation activities and contribute to safety sections of regulatory documents.
• Support the management and maintenance of DSPV operational documents, including ongoing review, update and alignment across processes.
• Draft and update departmental SOPs and other work practices as assigned
• Participate in training internal and external audiences on drug safety-related topics, as assigned.
• Contribute for Regulatory Authority inspections and audits.
• Good understanding of Safety Data Exchange Agreements and pharmacovigilance agreements.

Qualifications:

• Bachelor's/Advanced degree in life sciences, nursing, pharmacy, or related healthcare profession.
• Minimum of 7 years of relevant industry experience which includes at least 5+ years of drug safety experience in clinical and post-marketing settings.
• Experience with Argus safety databases, EDC systems, and electronic document management systems.
• Preferred to have pharmacovigilance experience with combination products and medical devices.
• Knowledge of GCPs, GVPs, ICH guidelines, and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.
• Independently plans and organizes work and effectively manages multiple priorities and responsibilities.
• Detail-oriented with good organizational and time management skills.
• Proficient in standard computer software (Word, Excel, 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.