US_Drug Safety Consultant II

Job Description

Job Description

Job Title: US_Drug Safety Consultant II
Duration: 12 Months
Location: Hybrid, Cambridge (2-3 days in office)

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).
In this role, you will:
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.
Essential Skills and Qualifications
Data Interpretation & Communication: Ability to understand, interpret, analyze, and clearly present scientific and medical data verbally and in writing (including medical concepts and terminology).
]Cross-Functional Collaboration: Proven track record of working collaboratively in a team environment across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external colleagues.
Clinical Judgment: Ability to apply clinical judgment to interpret case information and guide staff on case data evaluation.
Regulatory & PV Knowledge: Familiarity with pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations (including case processing, expedited reporting, and safety databases).
Organization & Independence: Strong organizational skills with the ability to prioritize tasks independently with minimal supervision.
Technical Proficiency: Basic knowledge of standard software (Excel, PowerPoint, Word, Business Objects) and familiarity with common safety database systems.
Education and Experience Requirements
Education: Bachelor's degree in biological or natural sciences required; Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
Experience: Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.

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