Senior Director, Head of PV Science
Alnylam Pharmaceuticals
August 20, 2026
Remote friendly (Cambridge, MA)
United States
Medical Affairs
Responsibilities
- Lead PV Science (PV Scientists/Fellows) and Aggregate Reports specialists; partner with Head of MSRM to develop/manage safety profiles across the product lifecycle.
- Operationalize PV risk management system (detection, assessment, minimization of risk) for investigational and marketed products.
- Collaborate on process improvements across signaling, clinical trial initiations, regulatory interactions, and aggregate report production.
- Manage PV Scientists’ participation in Investigator and Site Initiation meetings; ensure timely action items.
- Provide scenario planning, strategy analysis, portfolio prioritization, budget management, and forecasting (with MSRM).
- Lead development of SOPs, work practices, and training to standardize patient safety/risk management.
- Participate in audits/inspections; drive corrective actions with Global Safety Operations and other functions.
- Oversee safety committee operations (SRMT, SRMT Chairs, ESB) and prepare meeting materials.
- Lead signal detection via global medical literature monitoring.
- Oversee Development Risk Management Plans (DRMPs) and SME input to initial risk plans.
- Oversee aggregate safety report strategy and submissions: DSURs, PSURs, line listings; author strategy of safety analysis; manage health authority communications.
Qualifications
- Master’s or doctorate in medical/healthcare (MD, PharmD, RN) or relevant science.
- 12+ years pharma industry; 8+ years drug safety/pharmacovigilance; 5+ years managing teams.
- Advantage: RNAi therapeutics and rare disease experience globally.
- Required: leadership/team building; deep PV/regulatory knowledge (US/EU/LATAM/APAC) including device safety; safety operations (case processing, aggregate reports); matrix collaboration; business process improvement; Argus Safety Database and signaling tools (e.g., Empirica, PV Analytics); regulatory inspection readiness; planning/organization/budgeting; strong written/oral communication; adaptability.
- Special: represent PV Science as primary internal/external contact; lead cross-functional briefings/technical meetings; negotiation and scientific/analytic interpretation.
Benefits
- Comprehensive benefits: medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSA, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources and leave.
- Lead PV Science (PV Scientists/Fellows) and Aggregate Reports specialists; partner with Head of MSRM to develop/manage safety profiles across the product lifecycle.
- Operationalize PV risk management system (detection, assessment, minimization of risk) for investigational and marketed products.
- Collaborate on process improvements across signaling, clinical trial initiations, regulatory interactions, and aggregate report production.
- Manage PV Scientists’ participation in Investigator and Site Initiation meetings; ensure timely action items.
- Provide scenario planning, strategy analysis, portfolio prioritization, budget management, and forecasting (with MSRM).
- Lead development of SOPs, work practices, and training to standardize patient safety/risk management.
- Participate in audits/inspections; drive corrective actions with Global Safety Operations and other functions.
- Oversee safety committee operations (SRMT, SRMT Chairs, ESB) and prepare meeting materials.
- Lead signal detection via global medical literature monitoring.
- Oversee Development Risk Management Plans (DRMPs) and SME input to initial risk plans.
- Oversee aggregate safety report strategy and submissions: DSURs, PSURs, line listings; author strategy of safety analysis; manage health authority communications.
Qualifications
- Master’s or doctorate in medical/healthcare (MD, PharmD, RN) or relevant science.
- 12+ years pharma industry; 8+ years drug safety/pharmacovigilance; 5+ years managing teams.
- Advantage: RNAi therapeutics and rare disease experience globally.
- Required: leadership/team building; deep PV/regulatory knowledge (US/EU/LATAM/APAC) including device safety; safety operations (case processing, aggregate reports); matrix collaboration; business process improvement; Argus Safety Database and signaling tools (e.g., Empirica, PV Analytics); regulatory inspection readiness; planning/organization/budgeting; strong written/oral communication; adaptability.
- Special: represent PV Science as primary internal/external contact; lead cross-functional briefings/technical meetings; negotiation and scientific/analytic interpretation.
Benefits
- Comprehensive benefits: medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSA, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources and leave.