Aggerate Reporting Specialist

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

Primary 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 the cross functional lead and operational functions


• Oversees management of all line listings (6-month, 3-month, ad-hoc) for the PV Science group, including generation through submission


• Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties


• Identifies gaps in overall aggregate report processes and initiates change as appropriate

Other potential responsibilities:

• Works closely 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.


• Contribute to signaling and data mining activities utilizing internal and external sources of data.


• Perform signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests


• Develop knowledge of capabilities and limitations of various data sources.


• Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates utilized by Alnylam.


• 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.


• Proactively disseminates information to safety team members, providing context/urgency as applicable.


• Communicates clearly to all cross-functional areas including scheduling meetings to provide clarity and resolution of issues.


• Demonstrates alignment with Alnylam core values.


• Supports all SRMT preparation and documentation with guidance from mentor and safety physician.


• 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.


• Provide management and training for new staff on department practices and therapeutic area knowledge.

Education:

• Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required

Experience:

• A minimum of three to five 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 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 (e.G. Empirica, Spotfire).


• Experience and or understanding of regulations in the pharmaceutical industry.


• Skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs.


• Knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements.


• Strong planning, organization, written and oral communication skills.


• Experience in clinical patient care a plus

Special Skills:

• Ability to represent the functional department as internal and external contact on contracts and delivery for services relating to drug safety risk management.


• Manage cross-functional briefings and technical meetings for project stakeholders and customer representatives.


• Demonstrates diplomacy, reasoning, and problem-solving.


• Negotiation skills encouraging discussion and driving decisions to desired results.


• Strong analytic and scientific writing abilities.

Job Complexity:

• Involved Aggregate Report Management and in RMP across the product life cycle.


• Managing through cross-functions, business partners and CROs.


• Responsible for the successful implementation and management of activities contributing to risk management.

Supervision:

• Individual is expected to work independently with support from management and colleagues in GPSRM.