Category-Drug safety/Pharmacovigilance
Mission Statement:
In this role you will manage all internal and partnered Risk Management activities, being responsible for ensuring timely completion of all deliverables. To achieve this goal, you will write project plans and work with the Head of Risk Management to schedule meetings, establish timelines, assign tasks, track issues and assure completion of action items.
Responsibilities:
• Develop procedures that address the management of safety information to ensure proactive surveillance.
• Plan and lead case review meetings for all assigned products.
• Forge effective working relationships with medical leaders in Clinical development and Medical Affairs.
• Assess the benefit-risk balance for assigned products.
• Safety and benefit-risk management of assigned products and formulation of responses to regulatory inquiries on product safety issues.
• Work with the Medical Monitor in the review and assessment of analytical plans to evaluate safety issues and leverage necessary resources to respond to safety related issues and inquiries.
• Assess impact of detected safety signals and develop a signal strengthening action plan.
• Assist with Regulatory Agency inspections within Pharmacovigilance and ensures timely submission of aggregate reports.
• Support communication of potential safety issues, as well as activities and accomplishments to the Senior Management.
