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
Adverse event information collection, processing, tracking and distribution; Interact with health professionals and consumers regarding post-market adverse experiences, and clinical investigators and their staff regarding AE’s from clinical trials. 30%
Assist in projects requiring review and assessment of medical information obtained or related to adverse event reports, cumulative reports, or international regulatory reports and requests. 20%
Set standards for data collection and distribution processes; coordinates with others to assure policies are implemented. Assures regulatory and internal timeframes for the processing of adverse event information are met. Reviews data to verify accuracy and completeness of medical information and associated documentation. 30%
Interface with operational counterparts at Company affiliate and co-marketing partner locations, to assure the procedures and agreed implementation meet respective goals and regulatory responsibilities. 20%
Requirements
Application of clinical medicine to patient care
Medical terminology and standards of patient care
Communications, medical writing skills
Knowledge of International and US Regulations for reporting Adverse Events for Investigational and Marketed products.
Minimum 5-7 years experience in an industry application of clinical medicine/pharmacy, including a minimum of 3 years experience in International Product Safety
Knowledge of Clinical Development process in Pharmaceutical Industry
Experience in verbally interviewing and/or providing medical information to health care professionals.
Bachelor’s degree in medical field with RN or RPh licensure, or PharmD/MD degree required.
