- Collaborates with internal departments on implementation of quality principles and regulatory requirements related to Good Pharmacovigilance Practice (GVP)
- Coordinates PV-related aspects of inspection readiness activities
- Assists SABR and other Biogen Idec departments in addressing audit findings and development of Corrective and Preventative Actions (CAPAs)
- Participates in development and reporting of compliance metrics related to GVP activities
- Conducts effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunities
- Assist in hosting of regulatory inspections related to PV
- Applies departmental SOPs and participates in the development of departmental SOPs, as appropriate
- Responsible for maintenance, update, and change control of the Pharmacovigilance System Master File (PSMF)
- Monitors commitments from internal audit and regulatory inspection findings
- Performs late case investigations and writes delayed case reports
In depth understanding of clinical research and pharmacovigilance operations and regulations-in particular an excellent knowledge of ICH GCP, GVP as well as FDA, EU and ROW regulations
5 + years of experience in clinical research and/or pharmacovigilance, including compliance
Team player with excellent interpersonal skills
Strong attention to detail and excellent communication skills, both written and oral.
Excellent knowledge of SOPs and auditing/compliance background preferred
Bachelor's Degree required. Master's Degree preferred.
Biogen Idec - 20 months ago
Biogen Idec (NASDAQ: BIIB) is a global leader in the discovery, development and delivery of innovative therapies to improve the lives of...