ClinChoice Hiring Pharmacovigilance Safety System Analyst
Job Title: Sr. Pharmacovigilance Safety System Analyst
Employment Type: Full time
Location: Bangalore, India
About Clinchoice: ClinChoice is a clinical stage CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, India, Japan and the Philippines. It has over 1,800 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.
• 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 analyse 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 Material
• 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)
• 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.)
• Maintain knowledge of department policies and procedures
• Complete development activities as applicable
• Maintain 100% compliance in all assigned training activities
• 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)