Senior Associate, SABR Operational Excellence & Compliance
Biogen Idec - Cambridge, MA

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- 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

Location
US-MA-Cambridge

Job Category
Drug Safety

Requisition Number
19740BR

Qualifications
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

Education
Bachelor's Degree required. Master's Degree preferred.

Biogen Idec - 20 months ago - save job - block
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Biogen Idec (NASDAQ: BIIB) is a global leader in the discovery, development and delivery of innovative therapies to improve the lives of...