Post : Pharmacovigilance Process Expert
Job Description
Lead CMO&PS projects and support high complexity/criticality projects led by (Senior) Pharma-covigilance Process Managers. Act as process owner for assigned pharmacovigilance processes:
• Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
• Develop and maintain training material and communications for Novartis group and third party associates.
• Perform impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements.
• Lead assigned process improvement initiatives including IT projects/systems (leading en-hancements and managing releases).
• Analyze the impact of other process and organizational changes.
• Work in collaboration with the Compliance & Quality function to produce compliance re-ports and complete quality checks to monitor regulatory compliance as well as compli-ance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of ac-tions taken.
• Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of correc-tive and preventative actions.
• Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant to CMO&PS associates and other global line functions on regulatory requirements.
• Represent Novartis externally as a subject matter expert. Deputy process owner for high complexity / critical CMO&PS processes Mentor and train new starters in CMO & PS and associates from other Global Line Functions.
Lead CMO&PS projects and support high complexity/criticality projects led by (Senior) Pharma-covigilance Process Managers. Act as process owner for assigned pharmacovigilance processes:
• Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
• Develop and maintain training material and communications for Novartis group and third party associates.
• Perform impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements.
• Lead assigned process improvement initiatives including IT projects/systems (leading en-hancements and managing releases).
• Analyze the impact of other process and organizational changes.
• Work in collaboration with the Compliance & Quality function to produce compliance re-ports and complete quality checks to monitor regulatory compliance as well as compli-ance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of ac-tions taken.
• Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of correc-tive and preventative actions.
• Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant to CMO&PS associates and other global line functions on regulatory requirements.
• Represent Novartis externally as a subject matter expert. Deputy process owner for high complexity / critical CMO&PS processes Mentor and train new starters in CMO & PS and associates from other Global Line Functions.
Candidate Profile
PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable
• Minimum 2- 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance
• Experience of leading working groups.
• Procedural document writing experience
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international envi-ronment and across Global Line Functions
• Strong organizational skills
• Ability to mentor and coach
PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable
• Minimum 2- 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance
• Experience of leading working groups.
• Procedural document writing experience
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international envi-ronment and across Global Line Functions
• Strong organizational skills
• Ability to mentor and coach
Additional Information
Experience : 2 - 4 years
Qualification : PharmD, MSc degree in life sciences
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th February, 2019
Experience : 2 - 4 years
Qualification : PharmD, MSc degree in life sciences
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th February, 2019
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