Title: Pharmacovigilance Scientist
A small rapidly-growing bio-pharmaceutical company is seeking an experienced pharmacovigilance scientist to grow their pharmacovigilance team. You will play a key role in accelerating the development of a new-class of drugs to help those suffering with autoimmune diseases.
Responsibilities:
- Maintain and review aggregate reports.
- Manage and perform signal detection activities.
- Review and escalate AE/ SAE's.
- Manage vendors and ensure timely reporting.
- Review and contribute to SOP's, SMP's and SDEA's.
Requirements:
- Bachelor's degree in health or science related field.
- 3+ years of experience in the Pharmacovigilance space with project management experience.
- Knowledge of international regulatory submission guidelines
- Experience working with safety databases
- Experience with MedDRA coding
