1. Provide appropriate inputs to key strategic safety discussions to ensure success of development products and on market benefit/risk assessments.
2. Leverage expertise in local regulations to provide strategic direction for PV/device submission/approval & regulatory questions.
3. Offers expertise as necessary for creation of safety deliverables and at any local Health Authority review boards/meetings if needed.
4. Triage and translate affiliate product safety information needs to PPS Safety Science subject matter experts and ensure closed loop on information needs. Anticipate product safety information valuable to development assets.
5. Facilitate Affiliate medical teams’ understanding of benefit-risk position/messages and critical insights (e.g. safety topics discussed during dialog with regulatory agencies, post-marketing safety studies). Ensure readiness to implement post-marketing safety commitments.
6. Facilitate timely connection between Safety Science subject matter experts with Affiliate teams partnering with PPS to maximize success of development programs and regulatory filings and on market assets.
7. Liaise with affiliate/area cross-functional teams to proactively gather insights on regulatory and commercial strategies for development and late stage assets and provide PV/clinical safety expertise. Evaluate impact of these strategies on risk management planning and PV deliverables/activities. Connect with PPS and affiliate PV Teams to share relevant information and ensure readiness to support strategies.
8. Present product safety information at key affiliate, regional and global leadership meetings and provide appropriate local context to inform local business decisions/activities.
9. Share local safety insights with PPS Safety Science leaders to ensure these are considered within the context of Global PV strategies.
10. Facilitate best practice sharing across Area PV Product Leads and more broadly, across the International PV and PPS organization.