Back to jobsManage teams of PV Scientists and Fellows, as well as the Aggregate report specialists
Responsible for operationalizing PV Science department to provide continuous support in development, implementation and maintenance of a risk management system for detection, assessment and minimization of risk for investigational and marketed products
Work closely with the Head of MSRM and safety leads analyzing MSRM team’s needs and potential process improvements in all functions, including routine and ad-hoc signaling activities, clinical trial initiations, regulatory interactions, and aggregate reports production
Collaborate proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problem solving
Implement and monitor process enhancements and improvements
Manage participation of PV Scientists in Investigator meetings and Site Initiation meetings, ensuring effectiveness of the content delivery
In partnership with Head of MSRM, provide scenario planning, strategy analysis, portfolio prioritisation, budget management and forecasting
Responsible for ensuring the team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management processes. Lead development of relevant SOPs, work practices and training activities
Participate in audits, inspections and quality improvement initiatives. Proactively manage process improvements and collaborate with Global Safety Operation team and other functions to address relevant corrective actions
Oversee activities related to the functioning of Alnylam safety committees, including but not limited to, SRMT, SRMT Chairs and ESB meetings
Provide direction on relevant meeting material preparation
Ensure timely completion of all action items
Participate in relevant safety discussions providing scientific and operational contributions
Responsible for signal detection through global medical Literature monitoring
Oversee creation of Development Risk Management Plans (DRMPs). Responsible for SME contributions to initial Risk Management Plans
Lead the cross-functional collaboration between SRM, Regulatory Affairs, Medical Writing, Medical Affairs, and other functions for all activities related to regular updates of Risk Management Plans for approved products.
