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Vericel® Corporation · 17 hours ago

Manager/Sr. Manager, Pharmacovigilance Operations

Burlington, MA

Full-time

Hybrid

Senior Level

$109K/yr - $158K/yr

7+ years exp

Vericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care. The Manager/Senior Manager, Pharmacovigilance Operations will support the Pharmacovigilance Department by overseeing pharmacovigilance activities and vendor management, ensuring compliance and high-quality standards while managing multiple tasks effectively.

BiotechnologyLife ScienceTherapeutics

Responsibilities

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

Qualification

Pharmacovigilance experienceArgus safety databasesGCPsGVPs knowledgeMedDRA proficiencyWHO Drug dictionaries proficiencyVendor managementStandard computer softwareDetail-orientedOrganizational skillsTime management