What are the responsibilities and job description for the Senior PV Specialist position at ProPharma Group?
Job Description
ProPharma is the world's largest Research Consulting Organization, partnering with clients across the product lifecycle. We provide expert advice and services to biotech, med device, and pharmaceutical organizations.
About ProPharma
We have 20 years of experience improving patient health and wellness by empowering scientific breakthroughs and introducing new therapies.
Senior Pharmacovigilance Specialist, Case Processing
This role involves peer review of cases within the Case Processing team. Responsibilities include initial case-level assessment, quality checks, medical narratives, and generating queries for missing information.
Main Responsibilities:
- Oversee daily case processing of adverse event cases using MedDRA coding, determining seriousness and expectedness.
- Perform case follow-up activities, creating and reviewing case narratives, and providing client notifications.
- Develop training materials and deliver training sessions.
- Highlight areas of concern/discrepancies to Principal PV Specialist and/or Manager.
- Acquire and maintain knowledge of global safety regulations for medicines.
- Peer review cases for quality, consistency, and accuracy.
Necessary Skills:
- Strong verbal, written, and interpersonal communication skills.
- Intermediate project management skills.
- High level of accuracy and attention to detail.
- Able to work independently and collaboratively in a multi-disciplinary team.
- Excellent organization and prioritization skills; able to multitask.
Requirements:
- Bachelor's degree in life sciences (advanced degree or equivalent preferred).
- Three years of related work experience.
About Us:
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion, providing a safe space for all employees to succeed.