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    Senior Pharmacovigilance (Pv) Compliance Manager

    Parexel
    3+ years
    Not Disclosed
    Remote, USA
    10 July 1, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Senior Pharmacovigilance (PV) Compliance Manager, QA

    Location: Czech Republic or selected Eastern Europe countries

    Overview: Due to an expanding portfolio, Parexel is seeking a highly skilled and experienced Senior Pharmacovigilance (PV) Compliance Manager, QA. This role is crucial for ensuring compliance with Pharmacovigilance regulations, standards, and best practices. The ideal candidate will have extensive experience in auditing PV systems and processes and be able to document and demonstrate this expertise.

    Key Responsibilities:

    • Audits and Assessments:
      • Conduct comprehensive audits of PV systems, processes, and activities to evaluate compliance with applicable regulations, guidelines, and standard operating procedures (SOPs).
      • Assess documentation, databases, and records related to adverse event (AE) reporting, signal detection, risk management, and quality management systems (QMS).
      • Evaluate the effectiveness of PV systems in detecting, evaluating, and managing safety signals and ensuring appropriate risk minimization strategies.
    • Strategic Planning and Collaboration:
      • Support and oversee the three-year strategic PV audit plan for Parexel.
      • Collaborate with cross-functional teams, including Global Safety Surveillance (GSS), Quality, and Clinical Operations, to address audit findings and implement corrective actions.
    • Continuous Improvement and Mentorship:
      • Stay updated with the latest PV regulations, guidelines, and industry best practices.
      • Apply this knowledge during audits to ensure compliance and continuous improvement.
      • Provide guidance and mentorship to more junior PV auditors, facilitating their professional growth.

    Qualifications and Experience:

    • Professional Experience:
      • Extensive experience in safety/pharmacovigilance, including significant experience in GxP auditing, regulatory affairs, and quality assurance.
      • Proven track record in conducting audits of internal PV systems, processes, and activities to identify potential risks, gaps, and areas for improvement.
      • Excellent knowledge of Good Practices (GxPs) and international, national, and local regulations related to clinical trials and clinical research.
    • Skills:
      • Emerging ability to lead without explicit authority.
      • Strong self-management skills: independent, proactive, and organized.
      • Focused on quality results with attention to detail and first-time quality.
      • Excellent 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 within Quality and with Operations (and clients where assigned).
      • Skill in interpreting, synthesizing, evaluating, and extracting pertinent data to identify areas of risk, trends, and aggregated issues.
      • Adaptable to changing environments, able to think quickly, and manage ambiguity.
      • Cultural awareness with the ability to work globally.
      • Ability to travel as needed for the position.

    Education:

    • Bachelor's Degree or equivalent relevant experience required.
    • Preferred background in life sciences, health, or industry-related disciplines.

    This position offers a unique opportunity to contribute to the growth and compliance of Parexel’s Pharmacovigilance systems. If you meet the qualifications and are passionate about ensuring PV compliance, we encourage you to apply.

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