Manager/Sr. Manager, Pharmacovigilance Operations

Role 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.

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‚Äôs 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).