Senior Pharmacovigilance Compliance Manager

2 months ago


Uxbridge, United Kingdom Parexel Full time
Senior Pharmacovigilance Compliance Manager

Parexel is seeking a highly skilled and experienced Senior Pharmacovigilance Compliance Manager to join our team in the Czech Republic or other selected Eastern Europe countries.

Main Responsibilities:
  • 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.
Requirements:
  • Extensive experience in safety/pharmacovigilance, auditing, including sound experience of applicable GxP auditing, regulatory affairs, quality assurance.
  • Significant industry experience in conducting 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.


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