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 aartik.patel@kellyocg.com

or please feel free to share your referrals with us.