What are the responsibilities and job description for the Drug Safety Specialist position at GForce Life Sciences?
PV Aggregate Reports Scientist
12-month Contract
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.