Manager, Global Medical Safety

Kiniksa Pharmaceuticals•Lexington, MA

7d•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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