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: Head PV Process and Quality Excellence
Job Description
Responsible to lead the Pharmacovigilance Process and Quality Excellence activities and initiatives to streamline processes, drive performance, measure the performance on the agreed operational parameters in order to ensure that Novartis remains compliant with international regulations and Health Authority expectations. Lead and manage preparation of metrics reports, performance enhancement initiatives, audits and inspections preparedness, corrective and preventive actions, continuous improvement and leadership development. 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.
• Lead and manage the Pharmacovigilance Process and Quality Excellence activities and initiatives to streamline processes, drive leadership development, design programs to continuously improve performance on various operational parameters and ultimately ensure that Novartis remains compliant with international regulations and Health Authority expectations.
• 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.
• Design ,develop and sustain processes in ICSRs and Aggregate Reports as per the prescribed process governance mechanisms/instruments (P&SP, SOP, WP, WI, Manuals, Guidance documents) to meet the reporting requirements. Develop and maintain documentation for process updates, develop and maintain training material and archive the controlled versions
• Lead, develop and maintain metrics for the ICSRs and periodic reports generation performance including but not limited to regulatory compliance, process compliance, vendors performances (SLA based). Maintain trends analysis on a rolling basis for support of corrective actions, operational planning, regulatory inspections and preventive actions.
• Develop leadership in Global PV processes and quality management at Hyderabad through capability building, manage the efficiency gains through various initiatives and projects, drive compliance, develop ownership of processes in ICSRs and Aggregate Reports.
• Build the safety teams with challenging clear objectives in alignment with DS&E leadership objectives to facilitate implementation of strategic initiatives.
•Manage direct reports including Group Head - Process Excellence, Metrics & Analytics and Group Head – PV Quality Excellence and Inspection readiness.
• 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 entire Process and Quality Excellence group and support the Head of PV delivery (ICSRs& Aggregate Reports).
1. Number, timeliness and quality of deliverables according to established directives
2 Efficiency and productivity of Operations Group processes.
3.Recruitment, retention and development of talent in the group.
4.Operational risk mitigation and audit/inspection readiness
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Minimum requirements
Medical or Advanced Life sciences degree/Healthcare Professional or equivalent experience Fluency in English. Knowledge of other languages desirable. Safety management experience as head of safety for smaller pharmaceutical company, or as head of PV operation for KPO / CRO services company or in a senior Safety Leadership role (preferably global) in a Pharma MNC.
•8 to 10 years’ experience in drug development, including clinical safety or closely related areas of Development or equivalent combination of experience in clinical practice and life sciences
•3 to 5 years Management experience (Experience/exposure in a global setting mandatory) •Strong organisational, 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:
Experience: 3-10 years
Qualification: Life sciences degree
Location: Hyderabad
Industry Type: Pharma
End Date: 25th June, 2016
Job ID: 187952BR
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