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Pharmacovigilance Specialist
4 months ago
Functional Area Description
The group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Position Summary / Objective
Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections. Ensure pharmacovigilance regulatory compliance with oversight, as needed.
Position Responsibilities
- Participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key activities, milestones.
- Author and contribute to specified PV sections
- Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups.
- Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
- Collaborate within and across Client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
Experience Requirements:
- Minimum of 3 to 5 years BS/RN; 1 to 3 years MS/PharmD/PhD/MD, or equivalent relevant Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others.
Key Competency Requirements
- Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
- Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.
- Ability to work well in cross-functional teams.
- Good collaborative and communication skills with scientific subject matter.
- Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
- Understand aspects and methods for data analysis, interpretation and presentation.
- Possess good working skills in MS Word, Excel and PowerPoint, including statistics
