Job Openings for Senior Pharmacovigilance (PV) Safety System Analyst

Job Openings for Senior Pharmacovigilance (PV) Safety System Analyst

2 July, 2022

Job Openings for Senior Pharmacovigilance (PV) Safety System Analyst

Job Responsibilities

Project Management:

  • Ensure project methodologies are followed for all PV Systems projects
  • Ensure all PV Systems projects are delivered in accordance with current delivery standards

Business Analysis:

  • Partner with GMS business units & external partners for PV systems processes and PV system interface projects and opportunities, ensuring alignment with PV systems strategy
  • Act as a process subject matter expert, looking for ways to improve compliance, quality and efficiency
  • Elicit requirements using various techniques, critically evaluate the information gathered, reconciling conflicts, and distinguish user requests from the underlying true needs (requirements)
  • Proactively communicate and collaborate with external and internal customers to analyze information needs and create User Requirements Documents
  • Utilize enterprise-wide requirements definitions and management systems and methodologies
  • Manage process and system change, reducing the impact on the GMS business functions

User Acceptance Testing (UAT) Management:

  • Develop UAT scripts to test the requirements and regression test impacted functionality
  • Lead the execution of UAT, ensuring resource availability and timely execution of scripts
  • Review scripts for completeness and correctness and liaise with PV Systems provider to ensure timely documentation

Systems Implementation and Compliance

  • Plan and lead the implementation of new PV systems and major systems upgrades, interfaces with external systems
  • Manage CAPAs to closure, investigate root cause, identify corrective action and monitor effectiveness of implemented process/system retaining required documentation changes
  • Participate in PV Audits and Inspections
  • Manage the change process and ensure timely and relevant communication to appropriate groups

Controlled Documents and System Training

  • Provide subject matter expertise in the development and maintenance of controlled documents
  • Provide subject matter expertise to maintain systems training material and controlled documents in accordance with new systems releases
  • Contribute to new systems training materials and provide training to the appropriate subject matter experts

Vendor/Supplemental Contracting Resource Management/Oversight

  • Provide oversight and management of the first level off-shore Global Medical Safety (GMS) Support Desk
  • Ensure the off-shore teams are operating to current standard operating procedures and work instructions
  • Ensure the off-shore teams are meeting agreed Service-level agreement (SLAs) and are managing support requests according to current quality
  • standards Manage strategic partner/contractor resources leveraged for PV System related activities (e.g. UAT, document support activities, etc.)

Training and Development:

  • Maintain knowledge of department policies and procedures
  • Complete development activities as applicable
  • Maintain 100% compliance in all assigned training activities
  • Maintain industry and regulatory knowledge

Job Qualifications

  • BA or BSc degree in health-related field or other related scientific degree/qualification with an overall of 6 years’ experience and a minimum of 3 years of previous industry and/or clinical experience, or a minimum of 8 years of industry experience with a focus on pharmaceutical safety related areas.
  • Industry related experience within pharmaceutical safety related areas, including individual and aggregate reports
  • Knowledge and experience with single case safety reporting processes and regulatory compliance, and experience of international safety reporting /regulations
  • Knowledge of pharmacovigilance systems, with familiarity of a minimum of two commercially available systems
  • Knowledge of Quality Assurance for regulated computerized systems (FDA 21CFR part 11, GXP, EU directives & guidelines required)
  • Strong analytical, organizational, and process skills, including a thorough understanding of how to interpret business needs and translate them into application and operational requirements
  • In-depth knowledge of current working practices and procedures, with the ability to create process design documents
  • Identify and evaluate methods for improving efficiency, quality and regulatory compliance
  • Successfully engage in multiple work streams; strong interpersonal skills
  • Work with multiple stakeholders managing consensus and expectations
  • Create accurate and concise documentation
  • Ability to lead change
  • Ability to thrive in a global matrix environment
  • Excellent verbal, written and presentation skills
  • Excellent computer skills (e.g. standard MS Office tools)

If you are interested to apply for the role, please do share your CV at

or please feel free to share your referrals with us.

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