Sr. Manager, Medical Device Safety

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Employer:           Bristol-Myers Squibb Company

Position:              Sr. Manager, Medical Device Safety (Ref: 4185)

Location:             3551 Lawrenceville Road, Princeton, NJ 08540

Duties:  Serve as a senior subject matter expert (SME) on safety reporting requirements for medical devices & combination products by drawing on experience w/ medical device quality system regulations, including ISO 13485, 21CFR 820, 21CFR 803, EUMDR 2017/745, & combination product safety submission (21CFR Part 4b); understanding of global safety reporting regulations & guidelines, including the FDA, ICH, & EU Regulations & Requirements for Pharmacovigilance; Pharmacovigilance (PV) Safety Database; case processing, including knowledge of clinical trials/expedited ICSR submissions to health authorities; medical device & combination product submissions; complaint handling & customer service in the medical device or pharmaceutical industries; & clinical trials. Oversee post-marketing safety reporting of medical devices (21CFR Subpart H-Part 822) & combination product malfunction submission (21CFR Part 4b). Responsible for vendor oversight for medical device individual case safety report (ICSR) case processing. Participate in Quality Assurance related tasks for ICSRs, including review of cases, case correction requests, compilation of data, & presentation to the team. Track & ensure ICSR quality compliance & regulatory submission timelines. Collaborate w/ the manufacturing sites, device quality group, & product quality group for medical device safety reporting & risk management of the medical device & combination product-related complaints & ensure timely cross-functional evaluations of the complaints to support Pharmacovigilance compliance. Track & ensure compliance with internal & regulatory submission timelines. Responsible for the thorough review of the quality complaint database to identify device & combination product-related malfunctions, document, track, & provide relevant information for the ICSR process. Participate in updating the data entry manual & associated work instructions when new and/or updated conventions are introduced & train the team as appropriate. Identify & develop process improvements & database-related standard operating procedures, work instructions, job aids, & training materials within selected projects to meet short- & long-term objectives, including but not limited to compliance, productivity, & quality; work in a matrix environment to facilitate the allocation of required project resources; & deliver feedback on project deliverables. Support regulatory authority inspections & internal & external audits as a case management medical device safety SME. Partner with key stakeholders to develop a process & system for digital health safety reporting. Review large data sets, prepare reports for submission to the health authorities under strict timelines, & resolve respective queries regarding product safety. Provide expertise for the improvement of the Global Quality Database & Global Safety System for medical devices & combination product complaint records & ICSR case processing, respectively. Review, understand, & design safety reporting requirements for medical devices & combination products to meet global regulations.  Identify key project issues & identify potential solutions to effectively streamline processes, as well as collaborate effectively with project teams, business partners, vendors, & colleagues to ensure solutions are implemented in a timely & concise manner. Exercise a high degree of adaptability in dealing with an ambigu