Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, and 2017.
The Associate Director PV Science Drug Safety is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will oversee risk management plan activities including signal tracking maintenance, adhoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Alnylam products.
Summary of Key Responsibilities
- Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
- Responsible for coordinating and developing Risk Management Plans (RMPs) for Alnylam products among multiple stakeholders. Participate in the collection and analysis of data related to status and measurement of the effectiveness of risk management initiatives.
- Responsible for patient safety evaluation and development of Safety Management Plans.
- Contribute to signaling and data mining activities utilizing internal and external sources of data.
- Develop knowledge of capabilities and limitations of various data sources.
- Assist in the evaluation of potential safety issues and quality risk assessment reports.
- Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
- Contributes to the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
- Responsible for ensuring the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Drug Safety & Pharmacovigilance processes.
- Contribute as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritisation, budget management and forecasting.
- Establish expertise with data visualization tools (eg. Empirica, Spotfire)
- Manage and support the authoring for aggregate safety reports (eg. DSURs) in close collaboration with medical, medical writing and operational functions
- Provide management and training for new staff on Scientific Enablement practices and therapeutic area knowledge.
Degree in a medical or healthcare related discipline (MD, PharmD, RN), or high qualification relevant to scientific or business discipline.
A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in rare diseases therapeutic area at a global level is an advantage.
Strong skills and experience in;
- Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
- Ability to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
- Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
- Extensive knowledge of Argus, Arisg Safety Databases
- Knowledge of Signaling tools (eg. Empirica, Spotfire)
- Regulatory Inspection readiness
- Established skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPI’s & QPI’s
- Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
- Strong planning, organization, written and oral communication skills
- Experience in clinical patient care a plus
Ability to represent the functional department as primary internal and external contact on contracts and delivery for services relating to drug safety risk management. Lead cross-functional briefings and technical meetings for project stakeholders and customer representatives. Strong negotiation skills encouraging discussion and driving decisions to desired results. Strong analytic and scientific writing abilities.
Involved in RMP and Aggregate Report Management. Managing through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to risk management.
Position will report directly to Senior Director, Scientific Enablement. Individual is expected to work independently with support from management and colleagues in Drug Safety.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.