Senior Pharmacovigilance (PV) Compliance Manager

Due to an expanding portfolio, we have an exciting opportunity for a highly skilled and experienced Senior Pharmacovigilance (PV) Compliance Manager, QA to join our team in the Czech Republic or other selected Eastern Europe countries.

Candidates must have a strong knowledge and experience of audits of PV systems and able to document this in their CV and demonstrate it in an interview.

As a Senior PV Compliance Manager, you will play a crucial role in ensuring compliance of Parexel with Pharmacovigilance regulations, standards, and best practices. You will conduct audits of internal PV systems, processes, and activities to identify potential risks, gaps, and areas for improvement.

Main responsibilities are:

• Conduct comprehensive audits of Pharmacovigilance systems, processes, and activities to evaluate compliance with applicable regulations, guidelines, and standard operating procedures.
• Assess the documentation, databases, and records related to AE reporting, signal detection, risk management, and QMS.
• Evaluate the effectiveness of Pharmacovigilance systems in detecting, evaluating, and managing safety signals and ensuring appropriate risk minimization strategies are in place
• Support and oversee the 3 year strategic PV audit plan of Parexel
• Collaborate with cross-functional teams, such as GSS, Quality and Clinical Operations, to address audit findings and implement corrective actions.
• Stay updated with the latest Pharmacovigilance regulations, guidelines, and industry best practices, and apply this knowledge during audits to ensure compliance and continuous improvement.
• Provide guidance and mentorship to more junior PV auditors, sharing expertise and knowledge to facilitate their professional growth

Knowledge and Experience:

• Extensive experience in safety/pharmacovigilance, auditing, including sound experience of applicable GxP auditing, regulatory affairs, quality assurance.
• Significant industry experience in conduct audits of internal PV systems, processes, and activities to identify potential risks, gaps, and areas for improvement
• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research.
• English proficiency (written and oral)

Skills:

• Emerging ability to lead without explicit authority
• Self-management: independent, takes initiative, proactive and organized
• Focused on quality results - attention to detail and First Time Quality
• Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned)
• Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues
• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge
• Cultural awareness with the ability to think and work, globally
• Ability to travel as needed for the position

Education:

• Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred