Director of Pharmacovigilance
Director of Pharmacovigilance
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Pharmacovigilance professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Chief Medical Officer at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.
- 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
- Collaborate with EU Qualified Person for Pharmacovigilance to update Risk Management Plans (RPMs) and review Pharmacovigilance System Master Files (PSMF)
- 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
- 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.
- Develop, maintain and provide appropriate PV training for Company personnel
- Develop and manage annual safety budget
QUALIFICATIONS, EDUCATION AND EXPERIENCE
An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Healthcare professional (R.N., B.S.N., Pharm D, M.P.H., MD 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
- Experience with safety systems (ARGUS, ARISg or similar systems)
- Clinical trial research experience
- Strong analytic and communication skills
- Demonstrated ability to effectively collaborate with internal colleagues and external partners
- Preferred: experience working with CROs
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.