Position overview:
Manages the company-wide pharmacovigilance audit program, performs audits as required, and assists the Associate Director in the identification of issues and areas of risk. Communicates issues and risks to Senior Management and advises clients on mitigation strategies to correct and prevent further occurrence of identified issues. Interacts with both company and non-company clients on a global basis.
Responsibilities will include, but are not limited to, the following:
High Level
Implementing, and maintaining an effective pharmacovigilance audit program (global audit methods, techniques and criteria for establishing metrics).
Participating in the development of Corporate PV audit policies, SOPs, working practices & guidelines
Conducting/participating in audits as necessary.
Monitoring corrective action plans through use of existing company processes e.g. CAPA
In conjunction with the Associate Director, analyzing results of PV audits and communicating issues and areas of risk to Senior and Executive Management.
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 Senior Management.
Mentoring, training and developing staff.
Managing the audit program of companys pharmacovigilance activities versus company Standards and applicable regulatory requirements.
Performing Quality Control of the reporting of audit observations and the associated risk ratings applied to audit observations.
Serving as a pharmacovigilance compliance consultant, and providing regulatory guidance to customers.
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:
Detailed knowledge of Volume 9A and associated European directives , knowledge of individual EU member state PV requirements, and detailed knowledge of drug safety regulatory requirements in the US, Australia and Japan.
Expert knowledge of audit principles and concepts
Performs duties with minimal supervision.
International travel is a requirement (up to 30%)
Knowledge of Database set up and management
Excellent interpersonal, facilitation, presentation and communication skills (verbal and written) with demonstrable tact and diplomacy
Possessing a high level of maturity and character
Demonstrated ability to function in a team environment
Ability to lead others |