Manager, Product Safety (T)

Job Summary

• Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with co-marketing partners to meet assigned timeframes and to assure consistency of case records and documentation.
• Responsible for evaluating, tracking, documenting and processing adverse event reports received for assigned product, including the timely review and distribution to co-marketing partners and Company affiliate offices.
• Evaluates the need for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Company and co-marketing partner Safety offices, healthcare professionals and consumers to obtain and follow-up reports of possible adverse events for the assigned product area.
• Provides product information to health care professionals, consumers, sales representatives, and other Safety staff for all marketed and investigational Company products
• Designs and conducts quality reviews to verify the accuracy, completeness and validity of information for adverse event reports for the assigned product area, codes and enters information into the global safety database as required
• Creates and reviews individual and summary reports for submission to the FDA and International Regulatory authorities.
• Interface with other Company Departments and affiliates for dissemination of Drug Safety information, including training and orientation programs for Sales and Marketing, preparation and implementation of standard operating procedures, standardization of coding practices among International offices.
• Interface with Clinical for investigator training

Essential Functions

Requirements

This role is Hybrid