PV Quality and Compliance Specialist

PharmaSwiss, part of Bausch Health Companies, is one of the leading pharmaceutical companies in Serbia, that has been marketing its own and third-party products for many years now, while nurturing strong customer-oriented and consumer-centric approach in its everyday business. As a result, we are very proud of our strong reputation among healthcare professionals and consumers. Our goal is to make this leading position even stronger for years to come.

Join a team that's at the heart of healthcare innovation. A leader who develops, manufactures, and markets a diversified product portfolio across multiple high-growth therapeutic areas. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

To support our Global Pharmacovigilance Team, we are looking for:

PV Quality and Compliance Specialist

Responsibilities:

• Ensure the company's PV responsibilities regarding marketed products in EU and globally are fully met with regards to the pharmacovigilance quality management system.
• Assists GPRM functional SMEs and other Bausch Health sub-functional groups in activities relating to the investigation of deviations/findings and the development and oversight of corrective and preventative action plans in response to audit or inspection findings, or in response to internally identified trends in errors or other non-compliance.
• Regularly tracking and reviewing progress of CAPA deliverables, timely investigation and responses to deviations
• Support safety data reporting processes and procedures (working with appropriate and relevant divisional management) are compliant with national legislation.
• Compile monthly and annual compliance reports. Ensure all non-compliances are investigated and deviations raised where necessary, identifying root causes and ensuring the relevant PV personnel implement adequate and timeous corrective and preventative action (CAPA).
• Implement, maintain and comply with local PV QMS documents in accordance with Group Guidelines, Policies and Procedures, FDA, EMA, MHRA and international legislation and guidelines.
• Regularly tracking and reviewing progress of CAPA deliverables, timely investigation and responses to deviations.
• Assist with audit/inspection responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and or preventative actions for compliance with applicable regulations and guidelines.
• Supports in the preparation and follow-up of any internal or external audits and/or regulatory inspections impacting Pharmacovigilance from announcement until closure.
• Support Health Authority Inspections and PV audits as required in collaboration with Core Inspection/audit Team specifically in the area of document request management.
• Ensures that companies audit and/or inspection readiness activities comply with the business partner agreement and/or regulatory obligations, specific to pharmacovigilance.
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Requirements for the role:

• Medical or pharmaceutical educational background with a strong experience in pharmacovigilance or clinical safety related area with experience in quality related activities
• Minimum 2 years experience in PVG compliance and quality
• Audit/CAPA coordinator or Local Responsible Person for Pharmacovigilance experience preferred
• Expert knowledge of regulatory requirements pertaining to GVP, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally
• Knowledge of relevant FDA, EMA and International Conference on Harmonization (ICH) guidelines, including Good Vigilance Practices (GVP) guidelines. Working knowledge of MedDRA coding, PV Safety database (e.g. ARISg, ARGUS, etc), Deviation/CAPA system is a plus
• Solid skills and experience in quality systems, safety systems and tracking metrics, compliance monitoring
• Good planning, organizational and computer skills and understanding of business processes
• Excellent communication skills and ability to work within the team and cross-functionally
• Fluency in English