Description
DESCRIPTIONThe Safety Risk Leads (SRL) will perform proactive Safety Surveillance and Risk Management to effect product safety signal detection, risk assessment, and safety risk minimization. Will collaborate closely with relevant Safety Strategy Business Unit/Research Unit Leads to support appropriate safety strategies and meet safety strategy goals. Act as primary safety point of contact to asset teams, ensuring a unified communication on safety matters.
Responsibilities:
- Providing and accumulating DA-specific pharmacovigilance expertise, and applying this to various products
- Performing frequent proactive holistic safety reviews for products across the span of relevant available safety data information
- Ensuring consistency of safety risk messaging for a particular product or class of products, across multiple indications within the many safety reports and communications for that product
- Performing ad hoc special scholarly activities rapidly to meet specific needs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments
- Identifying opportunities for consistency and standards for approaches and processes
- Innovating, championing, and implementing Novel Approaches across engagement in continuous improvement initiatives, safety sciences research, and communications activities, including methodological improvements
- Platform for additional centers of excellence (eg Vaccines and Safety Advisory Councils)
- Engagement in inspection readiness and support
- Provisioning data to project managers for metrics and activity tracking
- Focuses intra- and inter- DA-Cluster sharing of information between related areas (eg safety knowledge of Pain vs Inflammation co-prescribing)
- Enables "Matrix assignment" to support Safety Strategy Leads
- 7+ years Medical Doctor experience
SKILLS
Medical Doctor (MD)
Synectics is an Equal Opportunity Employer.