Responsibilities
- Manages and oversees the company's drug safety and pharmacovigilance process
- Manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies
- Coordinates the development of guidelines and ensures the uniform and timely processing of adverse event reports
- Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements
- Oversees the development and preparation of reports for company management as well as external regulatory agencies
- Manages and conducts ongoing safety surveillance on company products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary
- Participates in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety
- Selects, develops and evaluates employees to ensure the efficient operation of the function.
- Act as Qualified Person (QP) within EU regulated countries and be responsible for batch certification and finished pharmaceutical products release in accordance with GMPs
Qualifications/Experience
Bachelor's Degree in any healthcare profession
Significant work experience in Drug Safety (especially operational PV) and qualification per training
Experience in Medical function (e.g. Clinical Research, Medical Information etc.) of a biopharmaceutical company
Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.
