Alnylam Pharmaceuticals · 13 hours ago
Associate Director, PV Science
Cambridge, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$169K/yr - $228K/yr
3+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, and they are seeking an Associate Director, PV Science to support the development and implementation of a risk management system for investigational and marketed products. The role involves overseeing risk management plan activities, collaborating with cross-functional teams, and ensuring the quality of medical authoring for product summaries and reports.
BiotechnologyHealthcarePharmaceuticalHealth CareMedicalTherapeutics
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
Qualification
Required
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
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
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
Experience in clinical patient care a plus
Preferred
Previous experience in managing drug safety personnel a plus
Specific experience in rare diseases therapeutic area at a global level is an advantage
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
Company data provided by crunchbase