Pharmacovigilance (PV) Scientist

• 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.
• Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Develop knowledge of capabilities and limitations of various data sources.
• Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates utilized by Alnylam.
• 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.
• Proactively disseminates information to safety team members, providing context/urgency as applicable.
• Communicates clearly to all cross-functional areas including scheduling meetings to provide clarity and resolution of issues.
• Demonstrates alignment with Alnylam core values
• Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
• Supports all SRMT preparation and documentation with guidance from mentor and safety physician
• Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties
• 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.
• Provide management and training for new staff on department practices and therapeutic area knowledge.
• Identifies gaps in overall processes and initiates change as appropriate.
  
  

Education: Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required

Experience: A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.

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, Arisg Safety Databases
• Knowledge of Signaling tools (e.g. Empirica, Spotfire)
• Experience and or understanding of regulations in the pharmaceutical industry.
• Skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
• 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
  
  

Special Skills: Ability to represent the functional department as internal and external contact on contracts and delivery for services relating to drug safety risk management. Manage cross-functional briefings and technical meetings for project stakeholders and customer representatives. Demonstrates diplomacy, reasoning, and problem-solving. Negotiation skills encouraging discussion and driving decisions to desired results. Strong analytic and scientific writing abilities.

Job Complexity: Involved Aggregate Report Management and in RMP across the product life cycle. Managing through cross-functions, business partners and CROs. Responsible for 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 GPSRM.

Job #: 25-22626