Manager, Global Patient Safety & Risk Mgmnt

Overview:

The Manager, Safety & Risk Management is responsible for supporting the safety team in the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. The Manager will have product responsibilities and work in conjunction with the Safety Product Leads for the product to oversee risk management activities including signal tracking maintenance, ad-hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs, PBRERs and RMPs for Alnylam products.

Key Responsibilities:

• Works closely with Safety Product Leads 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.
• Participate in the collection and analysis of data related to status and measurement of the effectiveness of risk management initiatives. In partnership with the Safety Product Lead, develop and maintain Risk Management Plans.
• Manage and support the authoring for aggregate safety reports (e.g., DSURs, PBRERs) in close collaboration with the Safety Product Lead and operational functions.
• Supports 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.
• Contribute to activities related to the functioning of Alnylam safety committees (e.g., SRMTs), including but not limited to, preparing slides, reports, minutes and other 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 Patient Safety and Risk Management processes.
• Contribute as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritization, budget management, and forecasting.
• Establish expertise with data visualization tools (e.g., Empirica, Spotfire)

Qualifications:

• Education: Degree in a medical or healthcare related discipline (MSN, PharmD, PA, MD,), or high qualification relevant to scientific or business discipline.
• Experience: A minimum of 1 year 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 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.
• Knowledge of Argus Safety Databases
• Knowledge of Signaling tools (eg. Empirica, Spotfire)
• Established skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
• Understanding of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Strong planning, organization, written, and oral communication skills
• Experience in clinical patient care is a plus
• Regulatory Inspection readiness experience is a plus

• Additional Skills: Ability to represent the functional department as primary internal and external contact on contracts and delivery for services relating to drug safety risk management. Support 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.
• Job Complexity: Involved in RMP and Aggregate Report Management. Coordination with cross-functional teams, business partners and CROs. Support the successful implementation and management of activities contributing to risk management.
• Supervision: Individual is expected to work independently with support from management and colleagues in SRM.

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About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. …