Pharmacovigilance Lead

POSITION SUMMARY

This position serves as the leader of PV for the company, ensuring compliance with reporting regulations and SOPs. SME for audits and FDA inspections.

ESSENTIAL FUNCTIONS

• Provide oversight and guidance for the day-to-day pharmacovigilance (PV) activities of PV partner (CRO)
• Ensure compliant safety reporting in accordance with local and international reporting regulations and standard operating procedures
• Ensure timely completion of periodic aggregate safety data reports (e.g., PBRER, PADER, DSUR, Annual Device Report, IND annual report), including coordinating internal reviews of these reports
• Responsible for review and triage of incoming individual case safety reports (ICSRs) and serious adverse events (SAEs) and direct follow-up with reporter as necessary
• Facilitate internal review of MedWatch/CIOMS reports
• Review safety database (ARGUS) to ensure accuracy and completeness of data, including review of MedDRA coding consistency
• Lead development of PV standard operating procedures and work guidelines
• Serve as the pharmacovigilance subject matter expert for internal audits and FDA inspections
• Review and update product Safety Management Plans as necessary
• Facilitate product safety review committee meetings
• Support due diligence activities and pharmacovigilance partner agreements
• Participate in signal detection and benefit-risk assessment activities; escalate possible safety concerns
• Contribute to addressing Health Authority safety queries
• Collaborate with the Pharmacovigilance team and CRO of our external partner MediWound taking regional responsibility for NexoBrid PV in North America and provide timely input to the preparation of Global safety reports for that product
• Oversee medical and scientific literature reviews for published articles relevant to the safety profile of products
• Provide input and support to the development and updating of safety sections of submission documents, Investigators Brochures, informed consents documents, aggregate safety reports, company core data sheets, product labels, etc.
• Provide periodic Pharmacovigilance training to internal and external partners as needed
• Develop and manage annual safety budget

QUALIFICATIONS, EDUCATION AND EXPERIENCE

• Healthcare professional (R.N., B.S.N., MPH, PharmD, or equivalent) with a minimum of 7 years of pharmaceutical or biopharmaceutical industry experience
• Minimum 5 years of relevant U.S. and EU drug safety/PV experience in the biotechnology/pharmaceutical industry
• Excellent knowledge of FDA, EU and ICH/GCP guidelines and regulations governing post-marketing safety surveillance
• Excellent knowledge of safety systems, particularly ARGUS
• Experience in the assessment and reporting of drugs, combination biologics and medical devices in the United States in accordance with FDA requirements
• Familiarity with EU and other international PV reporting frameworks
• Clinical research trial safety monitoring experience
• Strong analytic and communication skills
• Demonstrated ability to effectively collaborate with internal colleagues and external partners and CROs

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Occasional travel to nationals conferences

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