Pharmacovigilance Physician Oncology

Our client is a leading global Pharmaceutical Company, committed to improving lives, extending lives and saving lives - and they do it with increasing precision and efficiency through breakthrough science and innovation. We are looking for a Pharmacovigilance Physician to be based in their US office.

Job Description:
- Monitors the clinical safety of projects
- Performs medical assessment for single cases, including collecting additional follow-up information, medical evaluation of quality defects, review of line listings of single cases and preparation of investigator notifications
- Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools
- Provides input into responses to enquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards.
- Prepares medical input to aggregate clinical safety regulatory reports
- Provides input to safety profiling and risk management plan
- Provides expert evaluation on the clinical context of adverse event reports.
- Provides support for licensing activities, regulatory authority inspections and for project recall activities

Skills/Education:
-Medical Degree
-Fluent in English
-2 years medical experience postdoctoral
-2 years in drug development in pharmaceutical company including 1 years in drug safety
- Experience in preparing clinical safety assessments and regulatory reports/submissions involving safety information

If you meet the above requirements, please call Cherise on +44 (0) 207 255 66 00 or send an updated CV with a short cover letter, highlighting your relevant experience.

SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business