Aggregate Reports Specialist

Aggregate Reports Specialist - Contract - Cambridge, MA (Remote)

Help shape safer healthcare outcomes by driving aggregate safety reporting, signal management, and risk mitigation across the product lifecycle.

Proclinical is seeking an Aggregate Reports Specialist to join our client's team in the United States.

Primary Responsibilities:

As an Aggregate Reports Specialist, you will be responsible for the management of aggregate safety reports and Risk Management Plan (RMP) activities throughout the product lifecycle. Working closely with cross-functional teams, business partners, and Contract Research Organizations (CROs), you will support the effective implementation and oversight of drug safety and risk management initiatives.

The successful candidate will coordinate key pharmacovigilance activities, ensure the timely delivery of safety-related outputs, and contribute to the continuous improvement of safety processes. You will operate with a high degree of autonomy while collaborating with management and colleagues within the Global Patient Safety & Risk Management (GPSRM) function to support patient safety and regulatory compliance objectives.

Additional Responsibilities

• 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 our core values.

Education

• Degree in a medical or healthcare-related discipline 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.

The Aggregate Reports Specialist's responsibilities will be:

• In collaboration with the Aggregate Report Lead, PV Science Lead, and Safety Physician, 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 and bring issues related to SMPs and ESRPs forward for discussion with impacted stakeholders.
• Identify gaps in aggregate report processes and initiate process improvements as appropriate.
• Support aggregate report management and Risk Management Plan (RMP) activities throughout the product lifecycle.
• Manage activities across cross-functional teams, business partners, and CROs to support the successful implementation and management of risk management activities.