Medical Communications Specialist (Lynchburg, VA)
Fleet Laboratories’ 150+ year success story comes from adapting to a changing world with creative thinking and innovative product development. We've grown into a global leader of over 100 personal health and beauty products. Products you know, trust and use. As the world keeps evolving, we do as well... with unique new technologies and products that help you look and feel your best. Our commitment to quality and innovation has never been stronger. Working here at our location in Lynchburg, VA, you will feel part of an inclusive team that works together to meet our consumer needs.
We seek a Medical Communications Specialist who will be responsible for receiving, processing and reporting vigilance related communications from consumers, health care professionals, distributors, or other Prestige Consumer Healthcare (PCH) partners. The PCH Contact Center is typically the first point of contact for reports of serious adverse drug events and serious medical injuries; therefore, is a critical step in the data collection process and plays a major role in the pharmacovigilance system. Understanding the rules and regulations related to drug/device/supplement/cosmetic vigilance is critical to the role of the Medical Communications Specialist.
- Engage each consumer/reporter with the utmost honor, care, and concern to document, process and report vigilance related communications within the specified regulatory timeframes.
- Apply medical knowledge to assess adverse events, medical injuries, and cosmetic reactions (as applicable) for seriousness criteria, and causality at both the event and the case level .
- Follow Good Pharmacovigilance Practices (GPVs) and remain current with all applicable Global Pharmacovigilance Regulations
- Manage all drug/device/supplement adverse events, medical injuries and cosmetic reactions following SOP timelines and regulatory requirements.
- Proactively report potentially concerning safety events to management team.
- Ensure that all applicable pharmacovigilance policies and procedures are being followed.
- Enter data into the relevant database(s) using MedDRA and WHO drug coding.
- Maintain robust product knowledge and serve as product subject matter expert.
- Support the needs of the Quality Department by submitting quality evaluations for safety cases, as applicable.
- Perform case submissions for serious adverse events and serious medical device incidents for US, Australia and Canada.
- Submit PADER cases according to regulatory timelines.
- Adheres to requirements of distributor Vigilance Agreements (VA) and Safety Data Exchange Agreements (SDEA).
- Participate in pharmacovigilance and device audits and inspections.
- Participate in signal detection endeavors.
- Provide high quality customer service to consumers and health care professionals.
- Maintain high quality standards for data entry and database coding.
- Attend pertinent department meetings, of course!
- Perform other duties as required.
- BA/BS degree in Pharmacy, Nursing, or other medically related field.
- Licensed to practice in nursing, pharmacy, medicine (human or veterinarian), or as a coroner.
- Must have a minimum of three to five years' clinical experience.
- Must possess excellent computer skills
Prestige is an Equal Opportunity Employer
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