Associate Director, PV Science

Alnylam Pharmaceuticals

2d • Hybrid

About The Position

The Associate Director, PV Science 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, ad-hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Alnylam products.
Summary of Key Responsibilities
Lead 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.
Knowledge of literature review supporting signal detection.
Accountable for quality of the medical authoring of assigned product summaries and reports.
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 to work with product physician, affiliate management and regulatory to develop and edit Safety Management Plans /ESRPs and independently bringing issues related to these documents for discussion with impacted parties.
Work with Regulatory to ensure submission plan for regulatory documents.
Contribute to signaling and data mining activities utilizing internal and external sources of data.
Strong knowledge of capabilities and limitations of various data sources.
Assist in the planning and 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.
With oversight from product safety lead physician, will be responsible for analysis, collation and presentation of safety data to multi-disciplinary safety teams.
Will have depth of knowledge for Alnylam science, disease, and understands the interdependence of the studies within the program and the study strategy
Contributes to SOP and template development and maintenance
Contributes to the development the development of, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
Act as a subject matter expert for GPSRM processes and tools
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.
Proposes and implements innovative strategies and/or process improvements under direction of Senior members of GPSRM
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. PBRERs, DSURs) in close collaboration with medical, medical writing and operational functions
Provide management and training for new staff on department practices and therapeutic area knowledge.
Participates in inspection-readiness activities and inspections as required

Requirements

• Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
• 3-5 years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.
• 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.
• Knowledge of Argus, Arisg Safety Databases
• Knowledge of Signaling tools (eg. Empirica, Spotfire)
• Experience in regulatory Inspection readiness in regulatory inspections
• Established skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
• Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Strong planning, organization, written and oral communication skills
• Experience collaborating with Clinical Development, Regulatory Affairs, Nonclinical, GPSRM, and Medical Affairs
• Proficient knowledge in ICH GCP, drug development process and regulations
• Skilled in using Word, Excel, PowerPoint, reference management, and EDMS
• Experience in literature review for assigned products

Nice To Haves

• Previous experience in managing drug safety personnel a plus.
• Specific experience in rare diseases therapeutic area at a global level is an advantage.
• Experience in clinical patient care a plus

Responsibilities

• Lead 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.
• Knowledge of literature review supporting signal detection.
• Accountable for quality of the medical authoring of assigned product summaries and reports.
• 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 to work with product physician, affiliate management and regulatory to develop and edit Safety Management Plans /ESRPs and independently bringing issues related to these documents for discussion with impacted parties.
• Work with Regulatory to ensure submission plan for regulatory documents.
• Contribute to signaling and data mining activities utilizing internal and external sources of data.
• Strong knowledge of capabilities and limitations of various data sources.
• Assist in the planning and 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.
• With oversight from product safety lead physician, will be responsible for analysis, collation and presentation of safety data to multi-disciplinary safety teams.
• Will have depth of knowledge for Alnylam science, disease, and understands the interdependence of the studies within the program and the study strategy
• Contributes to SOP and template development and maintenance
• Contributes to the development the development of, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
• Act as a subject matter expert for GPSRM processes and tools
• 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.
• Proposes and implements innovative strategies and/or process improvements under direction of Senior members of GPSRM
• 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. PBRERs, DSURs) in close collaboration with medical, medical writing and operational functions
• Provide management and training for new staff on department practices and therapeutic area knowledge.
• Participates in inspection-readiness activities and inspections as required

Benefits

• We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match.
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees