Career for Gp Hd PV Quality & Inspection Readiness at Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Gp Hd PV Quality & Inspection Readiness

Job Description:
Responsible for the management of quality review of ICSRs & aggregate reports quality review and inspection readiness related activities for DS&E Hyderabad, in order to drive quality performance, quality improvement initiatives and to ultimately ensure that Novartis remains compliant with international regulations and Health Authority expectations. This would include all Global DS&E processes and quality metrics pertaining ICSRs & Aggregate reporting, in line with DS&E Quality Manual. Managing activities/interfaces with other Global Line Functions management, Novartis affiliates and Novartis Divisions management to ensure consistent cross-sector processes, efficient handling of adverse event & aggregate reporting, regulatory compliance and quality of safety information.
1. Responsible for the global management of quality review of ICSRs and aggregate reports for the entire Novartis Pharmaceuticals portfolio and deliverables delegated by other Novartis divisions to Novartis Pharmaceuticals, in order to drive quality performance, quality improvements and to ultimately ensure that Novartis remains compliant with international regulations and Health Authority expectations. It emcompasses deliverables managed in Novartis Pharmacovigilance sites and External Services Providers worldwide.
2. Lead management of activities/interfaces with other Global Line Functions management, Novartis affiliates and Novartis Divisions management to ensure efficient and compliant processes resulting in high quality safety information and to achieve a common understanding of other departmental needs.
3. Define, design and develop quality metrics for quality of ICSRs and Aggregate Reports within the procedural framework of Novartis (P&SP, SOP, WP, WI, Manuals, Guidance documents) and to meet the accuracy & completeness for the regulatory reporting. Develop and maintain procedural documentation, training material and archiving of the controlled versions.
4. Lead, develop and maintain quality related data including root-cause analyses for operational and compliance purposes including for performance improvements, process improvements, process simplifications, audits & inspections.
5. Build high performance quality review and inspection readiness teams with objectives in alignment with DS&E leadership objectives to facilitate implementation of strategic initiatives.
6. Lead and Manage Pharmacovigilance Team Managers. Responsible for ensuring recruitment, development of top safety talent and retention of high performing associates to maintain stable safety operations. Ensure regular performance evaluations, development and succession planning and manage other personnel management issues for the entire Quality Excellence group and support all the Pharmacovigilance team managers.
7. Ensure all the PV team including in-house and ESPs are inspection ready for the respective deliverables by supporting audit preparations, periodically sample and review audit related documents, review of processes and procedures.
8. Lead global teams to drive innovation, quality, productivity and continuous improvement within safety operations by leveraging people, processes and technology
1. Develop quality review related processes and quality parameters for ICSRs and PSURs
2. Generate and distribute quality reports to all key stakeholders in safety operations
3. Project management and completion on time.
4. Recruitment, retention and development of talent in the group.
5. Operational risk mitigation and audit/inspection readiness

Candidate Profile
•Life sciences degree/Pharmacist/Healthcare Professional or equivalent
•Good knowledge/fluency in English. Knowledge of other languages desirable.
•Extensive Experience in ICSRs processing/PSUR production and Quality initiatives
•Extensive experience in quality management and quality review related to PV deliverables.
•2 to 3 years Management experience (Experience/exposure in a global setting mandatory)
•Strong organizational, people and project management skills
•Strong negotiation and communication skills, and the ability to operate effectively in an international environ- ment
•Strong problem solving skills
•Ability to lead and deliver initiatives

Additional Information:
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Procurement
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 179416BR
End Date: 15^th January, 2016