Aggregate Safety Reporting Lead

Lancesoft; Cambridge (MA); On-site; USD 125,000 - 180,000; Full time

Job summary

Alnylam seeks a seasoned professional to lead and author aggregate safety reports (PSUR/DSUR/Line listings) in concert with the PV Science group and Safety Physician. You will oversee line listings, collaborate on SMP/ESRP development, and drive process improvements across a matrix organization.

Responsibilities include safety signal analysis, cross-functional teamwork with study teams and vendors, and contributing to dashboards and reporting for risk management.

Qualifications

• A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.
• Strong emphasis on applying process improvement methodologies and turning ideas into practical solutions.
• Ability to operate effectively in a matrix environment.
• Experience across diverse geographic regions and cultures is preferred.
• Pharmacovigilance, safety, or clinical science experience in biopharmaceutical development or medical affairs.
• Knowledge of Argus, Arisg Safety Databases.
• Knowledge of signaling tools (Empirica, Spotfire).
• Experience or understanding of pharmaceutical regulations.
• Skills in developing data displays (dashboards) for signaling, compliance, and KPIs/QPIs.
• Knowledge of global pharmacovigilance regulatory requirements (US, EU, LATAM, APAC).
• Strong planning, organizational, and written/oral communication skills.
• Clinical patient care experience is a plus.

Responsibilities

• Together with Aggregate Report lead, PV Science lead, and Safety Physician manages and leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with cross-functional lead and operations.
• Oversees management of all line listings for the PV Science group, including generation through submission.
• Works with affiliate management and regulatory to develop and edit SMPs/ESRPs and bring issues for discussion with impacted parties.
• Identifies gaps in aggregate report processes and initiates changes as appropriate.
• Works closely with safety physician to analyze potential safety issues, including signal detection, evaluation and management.
• Collaborates with study teams, cross-functional members, vendors to apply knowledge to problems in therapeutic areas.
• Contributes to signaling and data mining activities using internal and external data sources.
• Performs signaling data review from various sources (Empirica, Clinical/Safety outputs, literature, HA requests).
• Develops knowledge of data source capabilities and limitations.
• Assists in evaluating potential safety issues and risk assessments using Alnylam processes/templates.
• Contributes to Alnylam safety committees by preparing reports, minutes, meeting documents; tracks action items.
• Disseminates safety information to team members with context/urgency.
• Maintains clear communication across cross-functional areas and scheduling meetings for clarity.
• Aligns with Alnylam core values.
• Supports SRMT preparation and training under guidance from mentor/safety physician.
• Provides training for new staff on department practices and therapeutic area knowledge.
• Supports safety committees with documentation and discussions on patient safety issues.

Skills

Strong analytical skills

Scientific writing

Diplomacy and problem-solving

Negotiation skills

Cross-functional collaboration

Communication skills

Education

Degree in medical/healthcare discipline

Tools

Argus Safety Database

Arisg Safety Databases

Empirica

Spotfire

Job description

Alnylam seeks a seasoned professional to lead and author aggregate safety reports (PSUR/DSUR/Line listings) in concert with the PV Science group and Safety Physician. You will oversee line listings, collaborate on SMP/ESRP development, and drive process improvements across a matrix organization.

Responsibilities include safety signal analysis, cross-functional teamwork with study teams and vendors, and contributing to dashboards and reporting for risk management.