Executive Medical Director – PV & Drug Safety
SciPro has partnered with a Global Biotech making exciting strides in the development of innovative therapies in Neuroscience! With a rapidly developing pipeline of therapies - our client is looking to bring on an experienced PV physician to oversee & develop their Neuro products as well as manage the team.
As the Executive Director, you will report into the VP of Pharmacovigilance. You will be responsible for all PV activities for assigned products including aggregate reporting & signal detection, as well as interacting with internal and external stakeholders and global regulatory agencies.
Conducting safety activities including leading preparation and review of aggregate reports, signal evaluation, signal detection, etc.
Conducting Risk Management activities for assigned products, including content of RMPs/ REMS, assessments of benefit-risk, and advising on design of post-approval safety studies.
Provide medical insight, management & development to direct reports.
Communication with all external stakeholders and regulatory agencies.
Collaboration with cross-functional departments, demonstrating excellent written/spoken communication skills and ability to present technical information in a widely digestible manner.
Preparation of MAA/BLA/NDA submissions.
10+ years of Pharmacovigilance experience.
Excellent communication skills (writing, analytic, spoken).
Neuro PV experience preferred.
Knowledge of pre/post-marketed EU & US regulations.
Previous management experience.
Ability to work independently & collaboratively in a dynamic environment.