Drug Safety Specialist

Hybrid in Cambridge, MA (2-3 days on-site)

Must be able to work on a W2

Key Responsibilities

• Aggregate Report Management: Lead and conduct all aspects of aggregate safety reporting projects, including the authoring and project management of PSURs, DSURs, PADERs, and local reports, independently or collaboratively.
• Subject Matter Expertise: Serve as an expert on relevant safety requirements, company policies, and aggregate reporting processes. Represent and articulate these processes in cross-Safety and cross-functional forums.
• Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews.
• Conduct worldwide legislation reviews related to aggregate reporting and provide impact assessments.
• Health Authority Responses: Support the authoring of responses to safety inquiries from regulatory authorities in partnership with PV Scientists and key stakeholders.
• Cross-Functional Collaboration: Partner with Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, Quality Management, vendors, and external colleagues.
• Vendor & Quality Oversight: Work closely with vendors, vendor oversight, and Quality Management teams to maintain high-quality standards across PV documents.
• Process Optimization: Drive process improvement initiatives to enhance consistency across aggregate reporting, signal management, clinical trial safety oversight, and ad hoc safety responses.
• Process Implementation: Maintain existing procedures and support the implementation and rollout of new pharmacovigilance processes.
• Respond to safety questions from internal and external stakeholders while reviewing and supporting the authoring of medical and scientific safety information.

Essential Skills & Qualifications

• Ability to understand, interpret, analyze, and clearly communicate scientific and medical data, both verbally and in writing.
• Strong understanding of medical concepts and terminology.
• Demonstrated ability to work cross-functionally across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external partners.
• Ability to apply clinical judgment when interpreting case information and provide guidance on case data evaluation.
• Knowledge of pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations.
• Familiarity with case processing, expedited reporting, safety databases, aggregate reporting, and safety signal management.
• Strong organizational and prioritization skills with the ability to work independently with minimal supervision.
• Basic proficiency with Excel, PowerPoint, Word, and Business Objects.
• Familiarity with common safety database systems.

Education & Experience

• Bachelor’s degree in biological or natural sciences required.
• Advanced degree such as an MSc, PhD, MPH, PharmD, or equivalent preferred.
• Minimum of 5 years of Pharmacovigilance experience.
• Direct experience with aggregate safety report writing required.
• Experience with safety signal management required.