PV Case Processing Specialist
Location: United States
Job Category: Pharmacovigilance
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About ProPharma Group:
For the past 20 years, ProPharma has been improving patient health and wellness by providing advice and expertise that empower biotech, med device, and pharmaceutical organizations of all sizes. As the world's largest Research Consulting Organization (RCO), ProPharma partners with clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate high-profile drug and device programs.
The Position:
The PV Case Processing Specialist will be responsible for daily case processing of adverse event cases from clinical trials and/or post-marketing surveillance. The specialist will ensure compliance with regulatory requirements and client expectations while maintaining a high standard of quality and attention to detail.
Essential Functions:
Responsible for daily case processing of adverse event cases, including coding using MedDRA, determining seriousness and expectedness at both the event and case levels.
Perform case follow-up activities, including identification of information to be collected.
Create and review case narratives.
Provide client notifications as required for case management.
Support and contribute to the development of training materials and delivery.
Highlight areas of concern or discrepancies to the Principal PV Specialist, Case Processing, and/or Manager, Case Processing.
Acquire and maintain up-to-date knowledge of global safety regulations for medicines.
Conduct 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.
Ability to work independently and collaboratively in a multidisciplinary team environment.
Excellent organization and prioritization skills; able to multitask effectively.
Basic knowledge of Pharmacovigilance processes and requirements.
Educational Requirements:
Required: Bachelor's degree in life sciences.
Preferred: Advanced degree, RN, RPh, PharmD, or equivalent.
Experience Requirements:
Minimum of two years of related work experience.
Our Commitment to Diversity and Inclusion:
ProPharma celebrates differences and strives to create a workplace where every person can be their authentic self. We are committed to fostering a diverse, equitable, and inclusive environment. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Note:
ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please, no phone calls or emails regarding this posting.
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