Prestige Consumer Healthcare Company
Fleet Laboratories, Prestige Consumer Healthcare Company, the largest independent provider of over-the-counter in North America, has an immediate opening for the following position at its manufacturing facility located in Lynchburg, VA.
Supervisor, Medical Communications
The Medical Communication Supervisor reports to the Senior Director, Medical Affairs and Global Pharmacovigilance (PV). The Medical Communication Supervisor is responsible for supervising the Medical Communications team. The MCS Supervisor is also responsible for drafting high level medical and safety reports for domestic and international health authorities, drafts harmacovigilance global Standard Operating Procedures (SOPs) and assist with Arisg data entry and Quality Review (QC) review and Serious Adverse Event (SAE) submissions to FDA and other global Health Authorities on nonprescription products and devices.
• Supervise the Medical Communication Team and ensure adverse event and serious adverse event cases are processed per Regulatory Guidelines and Company SOPs
• Perform Scientific literature monitoring for Pharmacovigilance cases
• Monitor and report product safety trends via monthly, quarterly signal detection for all drug, device and dietary supplement products
• Research and monitor all applicable health authorities for current regulations, and apply findings in drafting and management of Pharmacovigilance Policies and SOPs
• Support MCS Team with PV data entry, QC Review, Medical Review and SAE submissions
• Assists with Pharmacovigilance Audits and Inspections
• Follow Good Pharmacovigilance Practices (GPVs) and remain current with all applicable Pharmacovigilance Regulations
• Performs PV data entry in ARISg
• Quality and Medically reviews AE and SAE cases in ARISg
• Maintains high quality standards for data entry and database coding.
• Responsible for ensuring PV SOPs are current and aligned with governing regulations
• Identifies areas and propose improvements for better efficiency.
• Perform other duties as required.
• BA/BS degree in a Medical Science-related field
• Industry and management experience, required
For consideration please e-mail resume with salary requirements to:
The deadline for accepting resumes will be Friday, April 12, 2019
We appreciate your interest in Fleet Laboratories. While we cannot respond to all inquiries, we will contact the qualified candidates whom we determine are the most suitable for the position.
EOE – M/F/D/V
Location/Region: Lynchburg, VA (24501)