Aggregate Reports Specialist

Shape Safer Healthcare Outcomes Through Aggregate Safety Reporting

Drive aggregate safety reporting, signal management, and risk mitigation across the product lifecycle. Join a team dedicated to supporting the effective implementation and oversight of drug safety and risk management initiatives while ensuring regulatory compliance and patient safety.

Primary Responsibilities

• Manage and lead the authoring of aggregate safety reports, including PSURs, DSURs, and line listings, in close partnership with cross-functional leads and operational functions.
• Oversee the management of all PV Science line listings, including 6-month, 3-month, and ad hoc line listings, from generation through submission.
• Partner with Affiliate Management and Regulatory to develop and edit SMPs/ESRPs and independently identify issues related to SMPs and ESRPs for discussion with impacted stakeholders.
• Support aggregate report management and Risk Management Plan (RMP) activities throughout the product lifecycle.
• Manage activities across cross-functional teams, business partners, and Contract Research Organizations (CROs) to support the successful implementation and management of risk management activities.
• Identify gaps in aggregate report processes and initiate process improvements as appropriate.
• Work closely with Safety Physicians to analyze potential safety issues, including signal detection, signal evaluation, and signal management.
• Collaborate proactively with study teams, cross-functional partners, external business partners, and vendors to apply scientific and analytical expertise to issues within specific therapeutic areas.
• Contribute to signal detection and data mining activities using internal and external data sources.
• Perform signal review using data from sources including Empirica, clinical and safety outputs, literature, and health authority requests.
• Develop an understanding of the capabilities and limitations of various safety data sources.
• Assist with the evaluation of potential safety issues and quality risk assessment reports using established processes and templates.
• Support activities related to safety committees, including preparation of reports, minutes, and meeting materials; tracking and ensuring completion of action items; and participating in discussions related to patient safety issues.
• Proactively communicate relevant safety information to team members, providing appropriate context and urgency.
• Communicate effectively with cross-functional teams, including coordinating meetings to facilitate clarity, issue resolution, and decision-making.
• Support SRMT preparation and documentation with guidance from the appropriate mentor and Safety Physician.
• Provide management and training support for new staff on department practices and therapeutic area knowledge.
• Demonstrate alignment with core values.

Education

A degree in a medical or healthcare-related discipline is required, such as:

• MSN/RN
• PharmD
• Physician Assistant
• MD

Experience & Qualifications

• Minimum of 3-5 years of experience in the pharmaceutical industry, with experience in drug safety and/or pharmacovigilance.
• Strong experience supporting the development and implementation of business process improvement methodologies and translating ideas into practical business solutions.
• Ability to work effectively in a matrix environment in accordance with company leadership commitments and values.
• Experience working across diverse geographic areas, business settings, and cultures preferred.
• Experience in pharmacovigilance, drug safety, safety science, clinical science, medical affairs, and/or other relevant areas of clinical biopharmaceutical development.
• Knowledge of Argus and Arisg safety databases.
• Knowledge of signal detection tools such as Empirica and Spotfire.
• Experience with, or understanding of, pharmaceutical industry regulations.
• Experience developing and implementing data displays and dashboards for signaling, compliance, departmental KPIs, and QPIs.
• Knowledge of global pharmacovigilance regulatory requirements, including US, EU, LATAM, and APAC.
• Strong planning, organizational, written, and verbal communication skills.
• Experience in clinical patient care is a plus.

Special Skills

• Ability to represent the functional department as an internal and external contact for contracts and service delivery related to drug safety and risk management.
• Ability to manage cross-functional briefings and technical meetings with project stakeholders and customer representatives.
• Demonstrated diplomacy, sound reasoning, and problem-solving skills.
• Strong negotiation skills with the ability to encourage productive discussion and drive decisions toward desired outcomes.
• Strong analytical and scientific writing skills.