Senior Manager, Drug Safety, IPV Operational Excellence Lead

Company Description

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Job Description

The International Pharmacovigilance (IPV) Excellence Lead drives a proactive approach to issue identification and resolution. The Excellence Lead enables IPV to limit risk and operate a high standard of pharmacovigilance practices/compliance across IPV operations (including Affiliates and International Partners) through implementation of continuous improvement initiatives.

What You’ll Do

• Contributes to the global strategy for PV oversight and compliance management within the IPV space;
• implements effective measures to monitor compliance and quality of key local PV procedures and operations (including but not limited to ICSR collection and Health Authority (HA) submissions, as applicable) in the post-marketing space;
• Connects with Affiliate and IPM network to understand and gather information on problem areas and barriers to execution.
• Reviews Audit and inspection observations and trends findings to establish common issues across the affiliate and international partner network
• Responsible for ensuring that the use of Affiliate PV Operations Vendors in the designated countries / regions are optimized including the governance strategy, supporting local safety heads to implementing against global strategy.

Who You Are

Passionate about PV processes including ability to identify gaps and using data to drive key business decisions. You are able to work across different levels within the organization, navigating and collaborating with people to drive resolution.

Qualifications

Required Skills

• Minimum of bachelor’s level degree, in pharmacy, medicine or relevant life science
• 5+ years in drug safety/pharmacovigilance in the pharmaceutical industry with PV operational experience in areas of processes
• Experience with interacting with third parties (e.g. PV operations vendors) required
• Knowledge of Good PV Practices and GVP regulations
• Direct experience in GxP compliant quality systems preferred
• Experience with Adverse Events Intake systems
• Experience in writing procedures, training materials and effectively delivering training to a diverse audience
• Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections preferred.

Additional Information

All your information will be kept confidential according to EEO guidelines.