Compliance officer Pharmacovigilance/Clinical Development
StemXpert1
Posted: February 27, 2014
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Quick Summary
The Compliance Officer will be responsible for ensuring the accuracy and compliance with regulatory requirements in the development of new pharmaceutical products, ensuring timely reporting and adherence to timelines.
Required Skills
Job Description
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Role: GPV Compliance Officer
Duration: 1 year
Type: Pharmaceutical
Environment:
Business Casual
Billable Rate Range:
$34.00 per Hour
Minimum Requirements:
Master’s degree or Doctoral degree in Pharmaceutical Science or Applied science preferred with minimum of 2 years’ experience in Pharmacovigilance or Clinical Development required .
Bachelor’s degree in nursing or applied science and at least 4 years’ experience in Pharmacovigilance or Clinical Development considered.
Very good knowledge of Pharmacovigilance relevant regulatory obligations including reporting rules and timelines.
Experience and good performance using MS Office programs and in working with databases.
Strong customer orientation, creative and conceptual thinking required related to metrics, reports and case investigations.
Analytic thinking required to detect patterns in data and derive improvement measures.
\Strong attention to details and proven ability to work in international and multicultural teams required.
Excellent command of English language verbal and in written a must.
Applicant must meet ALL of these requirements.
Description:
As part of the GPV Compliance Officer role the candidate will develop expertise in the following activities:
• Conducts root cause analysis (RCA) for late individual safety reports (single case handling for all CC and Pharma products)
• Performs detailed RCA analysis for late single cases reviewing case information in the ARGUS system and the PV Monitor CAPA database
• Conducts and documents thorough investigations
• Provides root cause analysis using the QAC defined CAPA coding and guidelines
• Communicates and approves corrective and preventative action(s) for non-compliance from multiple GPV external partners
• Tracks implementation of corrective action related to RCAs developed during the compliance investigations
• Compiles aggregate compliance data and participates in QAC generated metric reports
• Contributes to further development and enhancement of GPV CAPA analytical processes and projects
• Provides compliance analysis during inspections and audits as requested
• Presents RCA results at weekly Global QAC teleconference
• Supports development of business guidelines and SOPs
• Ensures timely and quality entry of CAPA investigations in PVM
• Works collaboratively with all QAC team members
• Consistently demonstrates sound analytical and compliance principles