Medical Communications Specialist 1 st Shift For over 150 years, Fleet Laboratories, a Prestige Consumer Healthcare Company, has adapted to consumer needs with creative thinking and innovative product development.

We are a global leader of over 100 personal health and beauty care products that consumers have come to trust : Summer’s Eve, Dramamine, Clear Eyes, Fleet Enema, Compound W, Luden’s, TheraTears, DenTek and dozens more helping people look and feel their best.

At Fleet Laboratories, the future is bright and our commitment to quality and innovation has never been stronger. Working here at our location in Lynchburg, VA, you will feel part of a team that works together to meet our consumer needs.

Fleet Laboratories is seeking a Medical Communications Specialist for 1 st Shift will reports to the Manager, Medical Affairs Systems and PV / Data Teams, and is responsible for receiving, processing and reporting vigilance related contacts 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.

WHAT YOU’LL DO Engage each consumer / reporter with the utmost honor, care, and concern to document, process and report vigilance related contacts 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, cosmetic reactions, and device incidents following SOP timelines and regulatory requirements.

Proactively reports possibly 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 Serious case submissions per regulatory timelines. Submits 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.

Actively participates in signal detection. Provide high quality customer service to consumers, health care professionals, company subsidiaries, and distributors.

Maintain high quality standards for data entry and database coding by asking comprehensive questions and obtaining detailed information when able (i.

e., lot #, pictures, product return, condition treating, medical history, patient demographics) Maintain a high level of knowledge associated with all platforms in which consumer contacts are received.

Attend pertinent department meetings. Writes clear, concise, grammatically correct, and medically accurate case narratives.

Notifies Manager or Supervisor immediately when late and arriving outside expected start times. Perform other duties as required.

Must have a minimum of three to five years clinical experience (direct and / or indirect patient care) Must have excellent computer skills.

Licensed to practice in nursing, pharmacy, medicine (human or veterinarian), or as a coroner, highly preferred. WHAT WE OFFER Here at Fleet, you can have a good job that can grow into a great career.

The start of a great career working with a diverse group of great people The health and safety of every employee... our top priority A clean, air-conditioned cGMP environment Top notch benefits paid time off, 401(K) retirement savings with company match, medical, dental and vision, pay annual targeted bonus, competitive pay, life insurance, Flexible spending account, and tuition reimbursement.

Stability a record of strong financial performance and part of a growing $1billion company A business supporting the Lynchburg community for over 150 years. Powered by JazzHR

Last updated : 2024-05-21