|Pharmacovigilance Process Lead|
|Global Drug Development|
|CMO & PATIENT SAFETY GDD|
|India Novartis Healthcare Private Limited|
|Research & Development|
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Job Description-: Cross-functional leadership of assigned Pharmacovigilance processes and maintenance of Global Operating Procedures (GOP), Working Practices (WPs), templates and business guidance documents in order to ensure compliance with global regulatory requirements.
1. Lead development and maintenance of the GOPs, WPs and templates for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
2. Drive cross functional process improvement initiatives and lead projects related to assigned processes; assembling the appropriate teams and supervising/directing their work.
3. Lead the business component of IT projects/systems related to assigned processes, leading enhancements and managing releases with impacted line functions.
4. Lead the resolution of queries from other functions and Country Organisations (COs) related to assigned processes and act as consultant to Patient Safety associates and other line functions on regulatory requirements.
5. Perform impact assessment on emerging regulations and ensure ongoing compliance of assigned processes to global regulatory requirements.
6. Establish clear processes for tracking (Key Performance Indicators), compliance reports and quality checks for assigned processes to monitor regulatory compliance as well as compliance to internal requirements and, in the case of any delays, investigate the root cause and implement corrective and preventative actions.
7. Develop the training and communication strategies for assigned processes for Novartis and third party associates and, produce and maintain the required training documents.
8. Act as the subject matter expert for assigned processes during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
9. Represent Novartis externally as a subject matter expert for assigned processes.
10. Support the Head of Pharmacovigilance Process Excellence and Metrics Analytics / Group Head of Pharmacovigilance Process Excellence and Metrics Analytics in developing and implementing operational strategy for assigned processes including outsourcing strategies.
11. Deputize for the Head of Pharmacovigilance Process Excellence and Metrics Analytics / Group Head of Pharmacovigilance Process Excellence and Metrics Analytics and assist with the recruitment of new staff.
Key Performance Indicator(s) – Number, timeliness and quality of deliverables according to established Health Authority directives and internal processes. Ability to lead cross-functional teams and interact with a wide variety of people at all levels. Drive continuous cross-functional business improvements by initiating and managing initiatives relative to assigned processes.
Minimum requirements- 1. Bachelor/Master’s degree in life sciences or related fields, PharmD or PhD degree in life sciences or equivalent experience Fluency in English.
2. Knowledge of other languages desirable Minimum 7 years of experience in the pharmaceutical industry, particularly Pharmacovigilance Leadership and (matrix) management experience. Ability to lead and deliver cross-functional initiatives.
3. Strong organizational and project management skills.
4. Strong negotiation and communication skills and ability to operate effectively in an international, matrix environment Ability to lead cross-functional work groups; deal and interact with a wide variety of people at all levels.
5. Experience of working with and supporting a team; ability to coach and mentor.