Aggregate Reports Specialist / Aggregate Reports Specialistess

Job Title: Aggregate Reports Specialist

Contract - Cambridge, MA (Remote)

Join us in shaping 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 manage aggregate safety reports and Risk Management Plan (RMP) activities throughout the product lifecycle. Collaborating closely with cross-functional teams, business partners, and Contract Research Organizations (CROs), you will support the implementation and oversight of drug safety and risk management initiatives.

• Coordinate key pharmacovigilance activities to ensure timely delivery of safety-related outputs.
• Contribute to the continuous improvement of safety processes while operating autonomously.
• Collaborate with management and colleagues within the Global Patient Safety & Risk Management (GPSRM) function to support patient safety and regulatory compliance objectives.

Skills & Requirements

You will also be responsible for:

• Analyzing potential safety issues in collaboration with Safety Physicians, including signal detection and management.
• Working proactively with study teams and external partners to apply scientific and analytical expertise.
• Conducting signal reviews using various data sources, including Empirica and clinical outputs.
• Assisting with safety committee activities, including report preparation and tracking action items.
• Communicating relevant safety information to team members with appropriate context and urgency.
• Providing management and training support for new staff on departmental practices.

Education

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

• MSN/RN
• PharmD
• Physician Assistant
• MD

Experience & Qualifications

The ideal candidate will possess:

• A minimum of 3-5 years of experience in the pharmaceutical industry, particularly in drug safety and/or pharmacovigilance.
• Experience in implementing business process improvement methodologies.
• Ability to effectively navigate a matrix environment in line with company values.
• Knowledge of Argus and Arisg safety databases, as well as signal detection tools.
• Strong planning, organizational, written, and verbal communication skills.
• Experience in clinical patient care is a plus.

Special Skills

The candidate should have:

• Ability to represent the functional department as an internal and external contact for drug safety and risk management.
• Strong analytical and scientific writing skills.
• Demonstrated problem-solving skills and the ability to negotiate effectively.

Responsibilities

The Aggregate Reports Specialist's duties include:

• Managing and leading the authoring of aggregate safety reports, including PSURs and DSURs, in collaboration with cross-functional leads.
• Overseeing PV Science line listings and working with Affiliate Management and Regulatory for SMPs/ESRPs development.
• Identifying gaps in aggregate report processes and initiating improvements.
• Managing activities across cross-functional teams to support risk management implementation.

If you are interested in this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.

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