PV Aggregate Report Scientist

About the role

This position is located in Cambridge, MA with a hybrid schedule of 2-3 days per week onsite.

Responsibilities

• Manage and author global aggregate safety reports, including PSURs/PBRERs, DSURs, PADERs, and local safety reports.
• Serve as a subject matter expert on global pharmacovigilance regulations, aggregate reporting requirements, and company PV procedures.
• Manage aggregate report timelines, including master schedules, production, stakeholder reviews, and regulatory submission requirements.
• Conduct worldwide regulatory legislation reviews and assess impacts on aggregate reporting processes.
• Support regulatory authority safety inquiries and responses in collaboration with PV Scientists and cross-functional stakeholders.
• Review and interpret medical, clinical, and safety data for aggregate reports and safety assessments.
• Partner with vendors and Quality Management teams to maintain compliance and quality of PV deliverables.
• Support safety signal management, clinical trial safety oversight, and ad hoc safety responses.
• Maintain PV procedures and support implementation of new and updated global pharmacovigilance processes.

Requirements

• Bachelor's degree in Biological Sciences, Life Sciences, Natural Sciences, or related field required. Advanced degree such as MSc, PhD, MPH, PharmD, or related discipline preferred.
• 5+ years of Pharmacovigilance (PV) experience.
• Hands-on experience with aggregate safety report authoring, including PSUR/PBRER, DSUR, PADER, and/or local reports.
• Experience with safety signal management and safety surveillance.
• Knowledge of global pharmacovigilance regulations and post-marketing safety requirements.
• Knowledge of clinical trial safety regulations and expedited safety reporting.
• Experience with safety case processing and safety databases.
• Experience interpreting clinical, medical, and safety data for PV assessments and regulatory reporting.
• Experience with aggregate reporting schedules, regulatory requirements, and submission timelines.
• Experience supporting Health Authority safety responses.
• Proficiency with Excel, Word, PowerPoint, and/or Business Objects.
• Experience with common pharmacovigilance/safety database systems.

Preferred Qualifications

• Advanced degree (MSc, PhD, MPH, PharmD) in a relevant scientific or healthcare discipline.
• Experience with worldwide legislation monitoring and regulatory impact assessments for aggregate reporting.
• Experience with vendor oversight and PV quality management.
• Experience implementing or optimizing global PV processes and procedures.
• Experience supporting clinical development, medical affairs, regulatory affairs, or clinical operations within a pharmacovigilance environment.

Pay

$79.62/hour