Manager, Global Medical Safety

Manager, Global Medical Safety Lexington, MA Job Details Full-time $152,000 - $160,000 a year 14 hours ago Qualifications Regulatory inspections Stakeholder engagement Microsoft Excel Microsoft Outlook Operations management Pharmacovigilance research Vendor management Clinical development Adverse event reporting Writing skills Corrective and preventive actions (CAPA) Training material drafting 3 years ICH guidelines Project management Doctor of Pharmacy Doctor of Philosophy Vendor relationship management Pharmacy Good Clinical Practice Regulatory submissions Training & development Senior level Regulatory audits Cross-functional collaboration Ad-hoc reporting Cross-functional team management Negotiation Cross-functional communication Overseeing training FDA regulations Stakeholder management Full Job Description Reporting to the VP, Global Medical Safety (GMS), the Manager, Global Medical Safety will be responsible supporting GMS to assess, track, and document the ongoing benefit-risk profile of all marketed products and those in clinical development. This includes (but is not limited to) providing thorough sponsor oversight of delegated safety responsibilities outsourced to safety vendor, leading operations in development of aggregate reports (e.g., DSUR, PAER), providing new hire AE/SI training, and planning Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings. This role interfaces across all levels of management and functional areas within Kiniksa to ensure timely management of all Global Medical Safety deliverables for both post-market and clinical stage products. This role is based in our Lexington, MA, office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. Responsibilities (including, but not limited to): Interact across multiple functions, supporting GMS operational activities Lead the daily management, operational oversight, and execution of delegated operational global medical safety tasks for all Kiniksa programs Provide Sponsor oversight of delegated safety responsibilities outsourced to safety vendor, including the timely and accurate execution of the processes defined within the applicable Safety Management and Safety Reporting Plans Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs while collaborating with the QA department Develop AE/SI training materials and lead new hire training to ensure proper AE/SI reporting for both internal Kiniksa employees but also vendors acting on Kiniksa's behalf Efficiently plan Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings, ensuring both senior GMS team members and key stakeholders provide input from their respective areas of responsibility In collaboration with GMS team, provide technical and scientific support for safety surveillance and signal detection activities for assigned products Oversee coordination and contribution to the production of periodic and ad-hoc safety reporting for therapeutic team products, ensuring thorough cross-functional reviews and timely submissions of documents to regulatory agencies Support for investigational products and registration activities including effectively collaborating with stakeholders outside of GMS, and representing GMS department in cross-functional clinical programs and registrational activities Support the preparation and implementation of any GMS related internal or external audits or inspections Support the review and maintenance of all

GMS SOPs and AE/SI Forms Qualifications:

Requires an advanced life science degree, (ie PharmD, PhD) or in a related science, with a minimum of 3 years of experience within the pharmaceutical industry or related field; minimum of 2 years of medical pharmacovigilance experience preferred. Ability to handle multiple demands in a fast-paced environment. Must be able to exercise appropriate judgment, as necessary. Requires a high level of initiative and independence. Excellent project management skills, attention to detail Highly self-motivated and able to handle multiple tasks in a timely fashion Familiarity of PC-based applications, including Microsoft Word, Excel, PowerPoint, and Outlook Analytical, solutions-oriented, negotiation, and strategic-thinking skills Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors Ability to synthesize and communicate (verbally and in writing) safety data and clinical/pharmaceutical information Working knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidance's related to pharmacovigilance (e.g., E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety Experience working with all levels of management and consulting with key business stakeholders Salary is commensurate with experience Kiniksa Benefits Summary - USA Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.