Summary of Duties and Responsibilities
This role will support Drug Safety, performs data triage of source documentation, confirms valid individual case safety reports and performs electronic submissions in the safety database. Tracks the status of AE reports and monitors metrics for compliance with ICSR reporting requirements to the FDA.
Performs data triage of source documentation and confirms valid individual case safety reports (ICSRs). Tracks the status of AE reports, performs electronic submissions and monitors metrics for compliance with ICSR reporting requirements to the global regulatory authorities.
Manages business partner exchange of AE reports in accordance with safety data exchange agreements and performs reconciliation.
Manages CRO case processing activities in the safety database with respect to compliance with safety agreements. Interacts with the daily operations of a contract research organization (CRO). Active participation in quality assurance and archival of safety data.
Evaluates and identifies areas needing improvement or clarification and drafts procedural changes and adaptations as needed.
Prepares SOP’s and work practice documents.
Prepares periodic safety reports for the FDA including quality review of narrative summaries and quality assurance of the data prepared by the CRO.
Bachelor’s degree required in a health care discipline.
BSN, PharmD, PA preferred.
Minimum of 5 years clinical safety or pharmacovigilance experience required.
Strong knowledge of safety monitoring and pharmacovigilance. Experience in medical writing, strong interpersonal and communications skills, as well as organizational and problem-solving skills. Ability to collaborate and interact with a wide range of health professionals and company personnel. Knowledge of preparation of periodic safety reports required.
Strong knowledge of FDA regulatory reporting requirements and GMP as well as GCP guidelines. Strong interpersonal, communication and organizational skills required.
5 years of industry experience out of which 3 must be in Drug safety required.
2-5 years of experience in ability to analyze laboratory data and review source documentation of ICSRs. Strong ability to construct narrative summaries of AE data from source documentation. Knowledge of regulatory reporting requirements and formats for the FDA and international regulatory authorities. Computer skills including knowledge of databases and querying databases for preparation of data analysis. Experience with adverse event coding dictionaries (MedDRA) required.
Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting required.
Ability to write periodic safety reports. Must have excellent written and oral communication skills required.
Must have resourcefulness and personal organization skills required.
Applies critical thinking skills to solve problems by generating, evaluating, and implementing solutions required.
Be open to considering new ways of doing things and the merits of new approaches to work required.
Work effectively with multi-disciplinary teams. Use teamwork skills to achieve goals, solve problems, and manage conflict required.
Take responsibility for accomplishing work goals within accepted timeframes required.
Pursue work with energy, drive and effort to accomplish tasks. Take initiative in seeking out new responsibilities and work challenges required.