Associate Director, PV Science
Alnylam Pharmaceuticals
Biotechnology
Philadelphia, PA - USA
Manager / Team Leader
Hybrid
Experteer Overview
In this role you will lead risk management activities for investigational and marketed products, collaborating with safety physicians and cross-functional teams to detect, assess, and minimize safety risks. You will oversee RMPs, safety reports, and signal management while ensuring regulatory readiness and robust data-driven insights. This position offers impact across global programs, shaping patient safety strategies and process improvements. You will work in a hybrid setup supporting a mission to advance rare disease therapies.
Compensation / Benefits
- medical, dental, and vision coverage
- life and disability insurance
- 401(k) with generous match
- paid time off, wellness days, holidays
- recharge breaks
- familial resources and leave
Responsibilities
- Lead signal detection, evaluation and management with the safety physician
- Coordinate and develop Risk Management Plans (RMPs) among multiple stakeholders
- Prepare and review aggregate safety reports (DSURs, PADERs, PBRERs) and related safety documents
- Collaborate with study teams, external partners and vendors to apply analysis across therapeutic areas
- Support safety data analysis for status and effectiveness of risk management initiatives
- Develop and edit Safety Management Plans / ESRPs with product physicians and regulatory partners
- Contribute to safety committee activities, reports, minutes, and action items
- Present safety data to multidisciplinary safety teams and support data visualization efforts
- Contribute to SOPs, templates, guidelines, and templates for risk management
- Act as subject-matter expert for GPSRM processes and tools
- Support process improvement initiatives and the development of standardized scientific working methods
- Provide training and mentorship to new staff on department practices and therapeutic area knowledge
- Participate in inspection-readiness activities and inspections as required
Key requirements
- Degree in a medical or healthcare related discipline (MD)
- 3-5 years in pharmaceutical industry with drug safety/pharmacovigilance experience
- Experience managing drug safety personnel is a plus
- Knowledge of Argus and Arisg Safety Databases
- Knowledge of signaling tools such as Empirica and Spotfire
- Regulatory inspection readiness experience
- Advanced knowledge of global pharmacovigilance regulatory requirements
- Strong planning, organizational, written and oral communication skills
- Experience collaborating with Clinical Development, Regulatory Affairs, GPSRM, and Medical Affairs
- Proficiency in Word, Excel, PowerPoint, EDMS
Description
In this role you will lead risk management activities for investigational and marketed products, collaborating with safety physicians and cr…
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