Manager, PV - Safety Writing

**Work Schedule**

Standard Office Hours (40/wk)


**Environmental Conditions**

Office


**Job Description**

Join us as Safety Writing Manager – And lead the efforts in managing and optimizing drug safety operations to ensure the highest standards of patient safety and regulatory compliance in clinical trials.

What You’ll Do:
• Manage the delivery of global aggregate safety reports, risk management plans (RMPs), regulatory authority assessment report responses, and custom safety reports, for both developmental and marketed products.


• Ensure that the team is provided with sufficient resources to deliver services in accordance with company policies and procedures, contractual agreements and applicable regulations.
• Maintain good communication with other functional groups concerning safety writing activities. • Prepare for and present proposals and bids on behalf of the Safety Writing Team.


• Pr...