Carolyne Rotich

AstraZeneca Pharmaceuticals

10.2022 - Current

Safety strategy and management teal leader (SSaMT-leader) in collaboration with Global safety physician, lead patient safety expertise to drive safety strategies, risk management and maintain the safety profile to enable quality, safety decision making and to deliver in a timely manner according to the project plan.
Provide subject matter expertise and leadership in the therapeutic area and across products.
Accountable for the safety sections of the labelling for CDS, SmPC and USPI.
Lead the safety surveillance strategy and the presentation of sophisticated safety issues to cross-functional teams and governance committees as well as periodic safety reports and health authority responses.
Partner with the GSP and other functional specialists to lead the safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA).
Participate in due diligence activities, negotiating the PV components of contracts/ agreements with third parties to ensure quality and integrity of these documents.
Provide training and mentorship to other PV Scientists and junior physicians.

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