What are the responsibilities and job description for the PV Case Processing Specialist position at 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.
1 year temporary/contract opportunity
