The Senior Manager, Pharmacovigilance & Epidemiology is responsible for or supports various pharmacovigilance and risk management/minimization activities for investigational and marketed products
Responsibilities (include but are not limited to):
- Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) in accordance with Kite SOPs and regulatory requirements
- Support preparation and maintenance of Risk Management plans
- Contribute to development of signal detection strategy for post marketed products
- Support signal detection, evaluation and management according to SOPs and guidelines
- Support development and/or maintenance of core and local label for products (e.g., CDS, USPI, SmPC, IB, etc)
- Serve as the Safety Lead for one more clinical programs
- Assist in oversight of PV vendors/CROs as applicable
- Contribute to preparing safety assessments reports
- Participate in preparing responses to safety related requests from health authorities
- Provide safety content review of clinical protocols, CSRs, and ICFs
- Bachelor’s level degree in life sciences required; PharmD or PhD highly preferred.
- At least 5 years of direct Pharmacovigilance Safety Science is required.
- Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines.
- Strong knowledge of safety database (preferably ARGUS), MedDRA, and WHO Drug
- Strong quality focus, with a good understanding of quality systems.
- Excellent communicator, both oral and written, specifically medical writing skills
- Ability to critically analyze individual and aggregate safety data with scientific rigor
- Previous experience in preparing periodic safety reports and risk management plans
- Excellent written and verbal communication skills to a variety of levels and teams, internally and externally.