Dr. Reddy’s Laboratories is looking for pharma candidates for the following post. To apply refer the details here.
Dr. Reddy’s Laboratories is a multinational pharmaceutical company. The company was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India. Dr. Reddy’s manufactures and markets a wide range of pharmaceuticals in India and overseas.
Dr. Reddy’s commenced its generics business in India in 1986 and is today a trusted name in the healthcare industry consistently serving the needs of millions of patients with high quality, affordable and innovative medicines across therapy areas. Dr. Reddy’s has built a robust field force driven by the zeal to make a difference in the lives of patients. The 5000-member strong team network connects with more than three lakh doctors on a regular basis to ensure that quality medicines we make are available for patients across the length and breadth of the country. Their efforts are backed by our unique inventory management system, VIVA (Viable Vision), to ensure that the medicines are available for patients when they need it.
Job Title: Pharmacovigilance Systems and Safety Data Lead
Qualification: B. Pharm, M. Pharm, Life Science Post Graduate
Experience: 8 – 13 Years
Job Location: Hyderabad
Salary: INR 20,00,000 – 30,00,000 PA.
Skills: Backend, Execution, Aris, Pharma, Functional Specifications, Reports, Process Improvement Initiatives, Data Entry, IT Projects, Monitoring
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.
- 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
- 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 an 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