Job Role Overview:
The position will be responsible for Pharmacovigilance auditing of Global Drug Safety, other company departments, Vendors, Affiliates, Contractual Partners and Systems to ensure compliance with company procedures and regulatory standards with regards to Pharmacovigilance. This individual will also be responsible for identifying opportunities for quality and process improvements within PVQA and interacting with both company and non-company clients on a global basis.
Responsibilities will include, but are not limited to, the following:
High Level
• Leading and implementing PVQA audit plans and activities to achieve departmental goals
• Developing, writing and revising PVQA SOPs and other quality system documents
• Developing, maintaining and administering the PVQA audit schedule
• Planning, performing, reporting and follow up of Audits of the Global Drug Safety group and other activities associated with this group including, Vendors, Affiliates, Contractual Partners
• Monitoring corrective action plans through use of existing company processes e.g. CAPA.
• Analyzing results of PV audits and communicating issues and areas of risk to the Associate Director, PVQA
• Consulting with auditees on development and implementation of effective resolution of compliance issues
Additional
• Working closely with Drug Safety teams to ensure that PVQA audit plans are implemented
• Developing relationships with key internal and external clients
• Monitoring current industry compliance trends and modifying audit program accordingly
• Analyzing the results of PV audits, generating metrics and periodic reports and communicating issues/risks to the Associate Director, PVQA
• Performing Quality Control of the reporting of audit observations and the associated risk ratings applied to audit observations
• Participating with preparation for and participating during Regulatory Inspections as required
• Tracking completion of agreed upon corrective actions as a result of pharmacovigilance audits and Regulatory Inspection commitments
• Identify opportunities for process improvement; plan, implement and evaluate changes in conjunction with corporate and department goals.
Skills/Knowledge Required:
• Working knowledge of Volume 9A and associated European directives , knowledge of individual EU member state PV requirements, and working knowledge of drug safety regulatory requirements in the US, Australia and Japan.
• Current knowledge of audit principles and concepts
• Perform duties with minimal supervision.
• International travel is a requirement (up to 30%)
• Excellent interpersonal, facilitation, presentation and communication skills (verbal and written) with demonstrable tact and diplomacy
• Demonstrated ability to function in a team environment
• Possesses a high level of maturity and character |