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Work as Pharmacovigilance Process Lead at Novartis

 

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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 : Pharmacovigilance Process Lead

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. Major Accountabilities
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.

Candidate Profile

  • Bachelor/Master’s degree in life sciences or related fields, PharmD or PhD degree in life sciences or equivalent experience Fluency in English.
  • 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.
  • Strong organizational and project management skills.
  • 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.
  • Experience of working with and supporting a team; ability to coach and mentor.

Additional Information:
Job ID:  233539BR
Experience: 7 years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
Location: Hyderabad
End Date: 8th March, 2018

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