Senior Pharmacovigilance Specialist

Job Description:

Responsibilities

• Responsible for overseeing and performing daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Supporting and contributing to the development of training materials and training delivery.
• Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality, consistency, and accuracy.
• Provide oversight and direction of PV deliverables as a PV subject matter expert as needed.
• Perform Health Care Professional (HCP) review (as required).
• Mentors and trains less experienced staff.
• Other duties as assigned.

Qualification & Experience

• Required: a Bachelor's degree in life sciences.
• Preferred: an advanced degree, RN, RPh, PharmD or equivalent.