Dr. Reddy Laboratories Ltd – Urgently Opening for Pharmacovigilance System and Safety Data

Job Description
Purpose:
The PV Project Manager is responsible for providing project management support for PV initiatives and process improvements, to ensure projects have appropriate planning, coordination and meet target timelines. The PV Project Manager will play a lead role in the overall planning, executing, monitoring, controlling and closing of PV related projects.
Responsibilities:
• Act as the PV Subject Matter Expert for the global safety database and associated systems
• Act as the primary liaison and first point of contact for:
o Internal DRL IT in support of safety database maintenance and changes
o The vendor supplier of the safety database and associated systems
• Provide system administration support for central safety database applications as appropriate
• Coordinate, implement and provide training for PV system projects and follow through the full project life-cyclev • Develop user requirements, functional specifications and propose solutions for unmet safety system business needs
• Analyze, collect, test, implement, and maintain safety database configuration changes
• Perform quality control check on configuration changes; identify discrepancies between the request and the implementation and resolve them or initiate their resolution
• Support testing and validation processes for pharmacovigilance IT projects; including generation of the appropriate documentation
• Develop, provide support to create complex specialized data outputs from the safety database for various Pharmacovigilance reports/ad hoc queries, as appropriate
• Ensure understanding of pharmacovigilance requirements and processes to support process improvement initiatives and the implementation of regulatory changes
• Provide training to new team members on the PV system, as required • Provide safety database SME support during audit and Regulatory Authority Inspections
Relationship Management
• Build relationships with key stakeholders (internal and external, including Pharmacovigilance Team, DRL IT and the safety database vendor)
• Define practices under the supervision of the Head of PV Operations and support to implement the same
Process Improvement / Standardization
• Assess existing processes vis–vis external benchmarks and industry best practices
• Identify areas of improvement and propose recommendations in functional reviews; develop and implement action plan for approved changes
Required Qualifications & Competencies
• B. Pharm, M. Pharm, Life Science Post Graduate. Ideally 6+ years
experience in the Pharma industry in either a pharmacovigilance data entry or Pharma IT role, but 2+ years must be in safety database management
• Experience of and excellent working knowledge of the LifeSphere Safety Database (formerly ARISg database managed by Aris Global), both from a front end (user interface) and back end (technical interface)
• Experience of retrieving data from relational databases
• Programming skills
• Experience of working on IT projects, GXP and validation requirements
• MedDRA dictionary handling and ARISg Drug Dictionary Management System knowledge
• Good teamwork and interpersonal skills
• Fluent in English (written and spoken)
• General knowledge of regulatory requirements for pharmacovigilance desired

Job Description
Purpose:
The PV Project Manager is responsible for providing project management support for PV initiatives and process improvements, to ensure projects have appropriate planning, coordination and meet target timelines. The PV Project Manager will play a lead role in the overall planning, executing, monitoring, controlling and closing of PV related projects.
Responsibilities:
Act as the PV Subject Matter Expert for the global safety database and associated systems
Act as the primary liaison and first point of contact for:
Internal DRL IT in support of safety database maintenance and changes
The vendor supplier of the safety database and associated systems
Provide system administration support for central safety database applications as appropriate
Coordinate, implement and provide training for PV system projects and follow through the full project life-cycle
Develop user requirements, functional specifications and propose solutions for unmet safety system business needs
Analyze, collect, test, implement, and maintain safety database configuration changes
Perform quality control check on configuration changes; identify discrepancies between the request and the implementation and resolve them or initiate their resolution
Support testing and validation processes for pharmacovigilance IT projects; including generation of the appropriate documentation
Develop, provide support to create complex specialized data outputs from the safety database for various Pharmacovigilance reports/ad hoc queries, as appropriate
Ensure understanding of pharmacovigilance requirements and processes to support process improvement initiatives and the implementation of regulatory changes
Provide training to new team members on the PV system, as required
Provide safety database SME support during audit and Regulatory Authority Inspections
Relationship Management
Build relationships with key stakeholders (internal and external, including Pharmacovigilance Team, DRL IT and the safety database vendor)
Define practices under the supervision of the Head of PV Operations and support to implement the same
Process Improvement / Standardization
Assess existing processes vis–vis external benchmarks and industry best practices
Identify areas of improvement and propose recommendations in functional reviews; develop and implement action plan for approved changes Required Qualifications & Competencies
B. Pharm, M. Pharm, Life Science Post Graduate. Ideally 6+ years experience in the Pharma industry in either a pharmacovigilance data entry or Pharma IT role, but 2+ years must be in safety database management
Experience of and excellent working knowledge of the LifeSphere Safety Database (formerly ARISg database managed by Aris Global), both from a front end (user interface) and back end (technical interface)
Experience of retrieving data from relational databases
Programming skills
Experience of working on IT projects, GXP and validation requirements
MedDRA dictionary handling and ARISg Drug Dictionary Management System knowledge
Good teamwork and interpersonal skills
Fluent in English (written and spoken)
General knowledge of regulatory requirements for pharmacovigilance desired

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