Assoc Director, Global Patient Safety & Risk Mgmnt

Overview

The Associate Director, International Safety & Risk Management is a combined role within the Safety and Risk Management (SRM) organization, reporting into the Head of SRM International & EU QPPV. This role in the SRM International function combines leading a Local Safety Office in an EU country and overseeing a region to develop, support, and drive excellence in post-approval pharmacovigilance activities for Alnylam products.  This role collaborates with the network of Local Safety Officers (LSOs), cross-functional Expertise Areas (EAs), and safety agreement partners to support and oversee the local and regional Alnylam Pharmacovigilance system ensuring local and regional compliance and supporting patients access to Alnylam products.

Key Responsibilities

• Establish and maintain strong relationships with LSOs, partnering expertise areas, and Safety Data Exchange Agreement (SDEA) partners within the given region to maximize opportunities for operational efficiency and regulatory compliance
• Identify and onboard LSOs in conjunction with any service providers, as needed
• Provide local and regional input into SRM activities and ensure the governance in place supports compliance with local legislation
• Participate in the development and implementation of pharmacovigilance and safety data exchange agreements (SDEA) and the oversight of partners in conjunction with other SRM functions and Alnylam Expertise Areas
• Ensure identification and assessment of risks related to regional pharmacovigilance activities. Communicate and escalate risks to SRM and cross-functional colleagues as appropriate.
• Support initiatives to expand the commercial footprint or product portfolio and formal PV impact assessment of such expansion activities
• Contribute to deviation and CAPA development to ensure actions are appropriate to address the operational issues concerned. Depending on the nature of the matter, this individual may be required to own the deviation and/or lead CAPA development.
• Support the development and maintenance of local PV procedures to supplement global procedures
• Support local and regional additional Risk Minimisation Measure implementation, tracking, decommissioning, effectiveness evaluation and maintain awareness of the activities
• Contribute to the development and implementation of measures to manage compliance and oversight of affiliates and license partners/distributors
• Work with cross-functional teams to advance continuous improvement activities to optimize productivity and quality
• Lead a Local Safety Office as Local Safety Officer in at least one  country within the region assigned. Manage Individual Case Safety Report (ICSR) collection, follow-up, translation, and submission activities as necessary to comply with local requirements
• Perform local literature screening in accordance with procedures and local requirements
• Participate in the development of local appendices for periodic safety reports
• Participate in development of the local Risk Managament Plan (RMP) and/or additional risk minimisation measures in collaboration with Medical Safety and Risk Management and other stakeholders
• Perform national regulatory intelligence surveillance regularly and act as subject matter expert for local pharmacovigilance and risk management requirements. Collaborate with other stakeholders and assess the impact for new and changing legislation and guidance.
• Handle safety-related interactions with the local regulatory authority.
• Collaborate with SRM and other stakeholders to fulfil safety-related requests from the local regulatory authority, report safety related signals and other safety matters to the local regulatory authority in accordance with local requirements.
• Support pharmacovigilance audits and inspections, serving as lead point of contact for internal local pharmacovigilance audits, as required
• Conduct/coordinate local pharmacovigilance training presentations
• Develop and maintain local pharmacovigilance procedures
• Act as local PV expert and primary PV contact for local matters. Advise SRM and local personnel on local PV requirements and maintain awareness of local PV-related activities

Qualifications

• Education: Bachelor’s degree in life sciences or related field.  Master’s degree preferred although not required.    
• Experience: Minimum of 10 years in the pharmaceutical industry with a demonstrated focus on pharmacovigilance operations and compliance in a global environment.
• Knowledge and understanding of relevant pharmacovigilance requirements for the given region, including legislation, Good Vigilance Practices (GVP) guidelines, trends, and industry standards
• Strong verbal and written communication skills
• Good presentation skills
• Proven ability to lead cross-functional initiatives
• Supervision: The position will report directly to the Head of International & EU QPPV.  ­­­­