Expert PV Case Processing Professional

Company Overview
ProPharma Group is the world's largest Research Consulting Organization, providing expert advice and consulting services to biotech, med device, and pharmaceutical organizations. With a focus on regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, we offer an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Job Description
As a Senior Pharmacovigilance (PV) Specialist, you will play a key role in ensuring the highest level of quality and commitment in carrying out all processes related to case processing. You will be responsible for peer review of cases within the Case Processing team, performing initial case-level assessment of expectedness, confirming seriousness, and generating queries for missing or unclear information.

Essential Functions

• Responsible for overseeing and performing daily case processing of adverse event cases, 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.

Necessary Skills and Abilities

• Strong verbal, written and interpersonal communication skills.
• Intermediate project management 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.
• Intermediate knowledge of Pharmacovigilance.
• Working knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.
• Legal/Medical case review experience preferred.

Education Requirements

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

Experience Requirements
Three years of related work experience.