Job ID: 230973BR
Position
Title: Pharmacovigilance Process Lead
Division: Global Drug Development
Business
Unit: CMO &
PATIENT SAFETY GDD
Country: India
Company/Legal
Entity: India Novartis Healthcare Private Limited
Functional
Area: Research & Development
Job Type: Full Time
Employment
Type: Regular
Sourcing Statement:
“You are applying to be part of the Novartis Talent
Pool.” We are not currently recruiting for this role but we are
building a pipeline for future opportunities. If you would like to be
considered for a similar position in future, then please submit your CV.
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.
Minimum
requirements
v Bachelor/Master’s degree in life sciences or related
fields, Pharm D or
PhD degree in life sciences or equivalent experience
v Fluency in English. Knowledge of other languages
desirable
v Minimum 7 years of experience in the pharmaceutical
industry, particularly pharmacovigilance Leadership and (matrix) management
experience.
v Ability to lead and deliver cross-functional initiatives.
v Strong organizational and project management skills.
v Strong negotiation and communication skills and ability
to operate effectively in an international, matrix environment
v Ability to lead cross-functional work groups; deal and
interact with a wide variety of people at all levels.
v Experience of working with and supporting a team; ability
to coach and mentor.
Last date to apply: 8th February, 2018
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