job title: pharmacivigilance specialist(propharma)

Essential Functions:

• Responsible for 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 as needed.

• Other duties as assigned

Necessary Skills and Abilities:

• Strong verbal, written and interpersonal communication skills.

• High level of accuracy and attention to detail.

• Ability to identify and resolve problems in a timely manner.

• Able to work independently and collaboratively in a multi-disciplinary team.

• Excellent organization and prioritization skills; able to multitask.

• Basic knowledge of Pharmacovigilance.

Educational Requirements:

• Required: a Bachelor's degree in life sciences.

• Preferred: advanced degree, RN, RPh, PharmD or equivalent.

Experience Requirements:

Two years of related work experience.