Pharmacovigilance Quality Assurance Professional - Belgium
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- The Pharmacovigilance Quality Assurance Professional will be in charge of implementing a strategy, including delivery of a risk based audit program covering the quality and compliance of the company Pharmacovigilance System(s).
- She/he will be also responsible to provide input and advice to processes and areas impacted by Good Pharmacovigilance Practice (GVP) with respect to the requirements of global and local regulations, guidelines and industry best practice
- Execute the Pharmacovigilance audit program (including audits of Central sites, Affiliates, Licensee, Contractors, specific processes and safety documentation) in support of clinical safety and Pharmacovigilance activities related to our products.
- Proactively manage findings, responses and CAPAs arising from audits in the Audit Database, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
- Participate in the development of the risk based PV audit program through evaluation of elements of the company clinical safety and Pharmacovigilance quality system and their effect on the overall state of compliance of the system.
- Lead the preparation, hosting and follow up of Regulatory Authorities inspections related to clinical safety and Pharmacovigilance activities at the Central sites, and lead or assist at Affiliate inspections as deemed necessary and practicable.
- Through active participation on the PV Quality Council and through direct interaction with colleagues, escalate concerns and provide expert guidance on PV compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
- Contribute data and feedback to Patient Safety, the Affiliate Network, and other functional groups relating to Key Quality/Performance Indicators and quality compliance status.
- Manage external auditors as required, ensuring that findings from internal audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the Audit Database.
- Play an active role as Business QA in validation of computerized systems supporting company’s Pharmacovigilance System
- Upon the request of/with the approval of the Head PVQA, perform other tasks within competence (as determined by relevant training, experience and/or qualifications).
- Master’s degree in a relevant scientific field
- Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in Pharmacovigilance-related areas.
- Experience in leading full range of Pharmacovigilance audits for internal processes/units and external partners or vendors, and in managing/hosting regulatory inspections or third party audits with depth of understanding of the theory and practice of quality management.
- In depth knowledge and understanding of Pharmacovigilance systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GVP principles, and practice. Able to apply theoretical knowledge in practical situations.
- Demonstrated self-starter, highly reliable, with positive, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
- Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with external inspectors, and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
- Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process.
- Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
- High level of personal integrity with a strong commitment to patient welfare and ethical behavior.
- Fluent in written and spoken English. Additional language skills would be an advantage.
- Able to travel nationally and internationally as business necessitates, up to 30% of time on average
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