Ensuring that the Local Operating Company

(LOC) safety activities, related to medicinal products are managed in
compliance with local regulations and company policies/procedures at local,
regional, and global levels and in accordance with any Pharmacovigilance (PV)
agreements with third party business partners.

Having appropriate pharmacovigilance risk

management systems and adequate record management in place to assure
appropriate oversight for products within its responsibility.

Managing Local Medical Safety activities

to:

• Ensure

proactive Benefit Risk Management throughout product life cycle translating
global safety data to insights and actions tailoring to local specificities and
needs.

• Support

activities related to safety reporting requirements as required by Marketing
Authorization Holders (MAH) and/or study sponsor, as applicable.

1. Safety Management