MSI are working with a globally recognised pharma company to help source a PV Case Management Head. The client are looking for someone with significant global experience and a strong knowledge of the case management and medical safety evaluation in clinical trial and marketed products.
Responsibilities for this role include:
· To improve and reinforce globally integrated case management standards, procedures, and systems in line with changes in the regulatory environment and best industry practices.
· He/she is directly responsible to implement and manage the overall adverse event case process, including but not limited to case management for marketing CHC products, safety evaluation, HA reporting, Product, Technical Complains (PTC), management of medical device/drug device combination products, PV inspection/audit for US, Japan, and EMA
· To build synergy and partnerships with other global PV departments, PV teams within the affiliates/regions and science hub as well as with the external partners.
· Ensure the vendors and distributors are qualified, high performing and motivated to accomplish the aligned objectives.
· Ensure proper planning and execution of the changes approved by upper management with appropriate funding. This includes the management of external vendors and budget tracking for case management activities.
· He/she contributes to safety management activities in cooperation with CHC Global Pharmacovigilance (GPV), Country PV teams, HA (Health Authorities), partner companies and other functions in compliance with global procedures and local regulatory PV requirements
· To systematically evaluate the availability of resources for ICSR management and keep them trained according to global SOP, WIN, and user manuals
· To be aware of local/regional legal requirements for case management and data privacy that impact the task and generate globally valid operating standards
· To drive business improvement for the tasks in collaboration with the involved CRO staff
· To solicit local regulatory obligations from appropriate subject matter experts and assess impact to the global standardized process
· To represent CHC global case management in all HA inspections and PV audits
· Case Management expert leading all discussions involving internal/external stakeholder and Partner company about case management
Education and Experience required for this role:
· PharmD or HCP/Equivalent with 10 years of Pharmacovigilance case management
· People management experience is preferred
· Knowledge of global and local PV regulations
· Strong knowledge of the case management and medical safety evaluation in clinical trial and marketed products
· Knowledge of PV safety system
· Appropriate experience of periodic reports, safety evaluation, risk management and communication with HA.
· Knowledge of Project management or experience
· Knowledge of PV Database and relevant PV tools used for PMDA
