Description
DESCRIPTIONThe Safety Risk Leads (SRL) in SSRM will perform proactive Safety Surveillance (SS) and Risk Management (RM) 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 assigned to the SRL operating from a SSRM DA-Cluster
- 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" from within SSRM to supporting Safety Strategy Leads
Qualifications:
- 7+ years Medical Doctor experience
SKILLS
Medical Doctor (MD)
Synectics offers competitive salaries and a full suite of benefits. EOE.