PV Scientist

The Fountain Group; Boston (MA); Hybrid; USD 150,000 - 180,000; Full time

Job summary

The Fountain Group is seeking a PV Aggregate Reports Scientist to join the Safety Surveillance and Aggregate Reports team. This role manages the processes for aggregate reports such as PSURs, DSURs, PADERs, and local reports, ensuring timely deliverables and regulatory compliance.

The position requires strong aggregate report authoring experience, collaboration across Safety, Clinical Development, Medical Affairs, Regulatory, and external partners, and fluency with pharmacovigilance databases

Qualifications

• Bachelor's degree in biological or natural sciences required; MSc/PhD preferred.
• Minimum of 5 years of Pharmacovigilance experience with aggregate safety report writing.
• Ability to analyze and clearly present scientific data.
• Experience collaborating across Safety, Clinical Development, Medical Affairs, Regulatory, and external colleagues.
• Familiarity with standard software and safety database systems.

Responsibilities

• Lead and conduct all aspects of PSURs, DSURs, PADERs, and local reports.
• Act as SME on worldwide aggregate reporting safety requirements.
• Respond to safety questions and support authoring of safety information.
• Coordinate with vendors and Quality Management to ensure high PV document standards.
• Drive process improvements for global PV processes.

Skills

Aggregate reporting

Pharmacovigilance

Cross-functional collaboration

Data interpretation

Education

Bachelor's degree in biological or natural sciences

Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred

Tools

Excel

PowerPoint

Word

Business Objects

Safety databases

Job description

Pay: $79.62/Hour

Duration: 1 year

Location: Hybrid, Cambridge (2-3 days in office)

Must have strong aggregate report authoring experience

Position Summary

The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports).

• Serve as a subject matter expert on worldwide aggregate reporting safety requirements for the PV Scientist team, Safety, and cross-functional partners.
• Respond to safety questions from internal and external stakeholders while reviewing and supporting the authoring of medical and scientific safety information.
• Work closely with vendors, vendor oversight, and Quality Management teams to ensure high quality standards across PV documents.
• Support process improvement initiatives in collaboration with PV Sciences and cross-functional groups to develop, implement, and maintain compliant, efficient, and consistent global PV processes.

Key Responsibilities

Aggregate Report Management: Lead and conduct all aspects of substantive projects, including the authoring and project management of PSURs, DSURs, PADERs, and local reports independently or collaboratively.

• Subject Matter Expertise: Act as an expert on relevant safety requirements, company policies, and aggregate reporting knowledge; represent and articulate processes in cross-Safety and cross-functional forums.
• Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.
• Health Authority Responses: Support authoring responses to safety inquiries from regulatory authorities alongside PV Scientists and key stakeholders.
• Process Optimization: Drive process improvement initiatives to enhance consistency in aggregate reporting, signal management, clinical trial safety oversight, and ad hoc safety responses.
• Implementation: Maintain existing procedures and support the rollout of new PV processes.

Qualifications

• Bachelor's degree in biological or natural sciences required; Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
• Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.
• Ability to understand, interpret, analyze, and clearly present scientific and medical data verbally and in writing (including medical concepts and terminology).
• Proven track record of working collaboratively in a team environment across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external colleagues.
• Ability to apply clinical judgment to interpret case information and guide staff on case data evaluation.
• Familiarity with pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations (including case processing, expedited reporting, and safety databases).
• Basic knowledge of standard software (Excel, PowerPoint, Word, Business Objects) and familiarity with common safety database systems.