Kim Mc Kinnell
About Kim Mc Kinnell
Kim Mc Kinnell is the Senior Director of Safety Signaling and Aggregate Reporting at Alkermes, with extensive experience in pharmacovigilance and regulatory safety reporting.
Current Position at Alkermes
Kim Mc Kinnell currently serves as the Senior Director of Safety Signaling and Aggregate Reporting at Alkermes. In this role, she leads a team of Pharmacovigilance (PV) Scientists, ensuring the processes and performance of safety signaling and aggregate report generation are compliant with both domestic and international regulations. She actively participates in safety teams to support risk management activities, including signal detection, tracking, and maintaining Risk Management Plans.
Previous Positions at Alkermes
Before her current role, Kim Mc Kinnell worked as the Director of Safety Signaling and Aggregate Reporting at Alkermes from 2017 to 2021. Her responsibilities included authoring regulatory safety reports across multiple therapeutic areas such as Immunology, Oncology, and Neurology. During her tenure, she demonstrated strong project management skills, coordinating planning, setting timelines, and managing teams within a matrix environment.
Employment History at Biogen
Kim Mc Kinnell worked at Biogen from 2014 to 2017. She held the positions of Associate Director of Aggregate Reporting and Senior Pharmacovigilance Scientist. In these roles, she gained extensive experience in authoring responses to health authority requests and health hazard evaluations. She also participated in safety teams to support various risk management activities, showcasing her adeptness at managing regulatory authority requests and maintaining Risk Management Plans.
Experience at Janssen Research & Development
From 2007 to 2014, Kim Mc Kinnell was employed at Janssen Research & Development. She served as a Manager and later as a Senior Scientist in Aggregate Reporting. Her work involved a thorough understanding of GCPs, GPvPs, and ICH guidelines. She was crucial in ensuring compliance with pharmacovigilance regulations and demonstrated her leadership abilities while managing teams focused on pharmacovigilance and aggregate reporting.
Educational Background
Kim Mc Kinnell holds a Master of Science (MS) in Quality Assurance Regulatory Affairs from Temple University, which she earned from 2013 to 2016. Prior to that, she achieved a Bachelor of Science (BS) in Biology from Temple University, graduating in 1994. Her formal education provided a solid foundation for her extensive experience in pharmacovigilance and safety reporting in the biopharmaceutical industry.