Research Aggregate Reports Specialist

Alnylam Pharmaceuticals•Cambridge, MA

7d•Onsite

About The Position

This role is responsible for managing and leading the authoring of aggregate safety reports, such as PSUR, DSUR, and Line listings, in close collaboration with cross-functional leads and operational functions. The specialist will oversee the management of all line listings for the PV Science group, including generation through submission. They will also work with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently address issues related to them. Additionally, the role involves identifying and initiating improvements in overall aggregate report processes. Other responsibilities include analyzing safety issues with the safety physician, contributing to signal detection and evaluation, collaborating with various teams and external partners, and performing signaling data reviews from multiple sources. The specialist will develop knowledge of data source capabilities and limitations, assist in evaluating safety issues and quality risk assessments, and contribute to the functioning of Alnylam safety committees by preparing reports, minutes, and ensuring action items are completed. They will also disseminate information to safety team members, communicate clearly across functional areas, and support SRMT preparation. The role includes providing management and training for new staff.

Requirements

Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
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.
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
Ability to represent the functional department as internal and external contact on contracts and delivery for services relating to drug safety risk management.
Demonstrates diplomacy, reasoning, and problem-solving.
Negotiation skills encouraging discussion and driving decisions to desired results.
Strong analytic and scientific writing abilities.

Nice To Haves

Preferably with experience of working across diverse geographic areas, business settings and cultures.
Experience in clinical patient care a plus

Responsibilities

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
Works 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
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.
Performs 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
Provide management and training for new staff on department practices and therapeutic area knowledge.
Manage cross-functional briefings and technical meetings for project stakeholders and customer representatives.
Responsible for the successful implementation and management of activities contributing to risk management.