Drug Safety Consultant II

Job Description

Job Summary:

• 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.

Duties and 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.

Education and Experience:

• 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.

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.