Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
This role consists of primarily auditing against Good Pharmacovigilance Practice (GVP) regulations and guidelines. Audits include Celgene Affiliates, Partners and Vendors; as well as key Processes/Systems e.g. Case Processing, Aggregate Safety Reports and Risk Management Plans.
Auditors are responsible for the planning, conduct, reporting and verification of audit related commitments throughout the audit lifecycle until closure including maintenance of the PSMF sections related to audits.
Other responsibilities will include participating in projects within both the GVP Corporate Audit group and the Corporate Audit and Inspection Group; projects may include but are not limited to process improvement initiatives and strategic innovation opportunities.
The ideal candidate will have strong background knowledge of all Pharmacovigilance responsibilities undertaken by a Marketing Authorisation Holder and the quality background to ensure audits are conducted efficiently and in accordance with the GVP Corporate Audit group expectations.
Please note, that on average, 25% domestic and international travel will be required. This role can be based at our UK (Stockley Park) or US (Summit, NJ) offices.
Role and Responsibilities
Skills and Experience required
Competencies associated with this role
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.