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 Manager
Job Description
Lead assigned cross functional and CMO&PS projects. Act as process owner for assigned higher complexity 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.
Lead assigned cross functional and CMO&PS projects. Act as process owner for assigned higher complexity 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.
• Support 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 Func-tions on regulatory requirements.
• Represent Novartis externally as a subject matter expert. Work jointly with Compliance & Quality and Process Compliance & Risk Mitigation functions to perform metrics trend analyses, generate knowledge and mitigate any identified risks. Mentor and train new starters in CMO&PS and other Global Line Functions. Collaborate with other Global Line Functions across Novartis Divisions to meet joint accountabili-ties.
Candidate Profile
PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable.
• Minimum 4 - 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance.
• Experience in project management and demonstrated abil-ity to lead work groups in a matrix environment.
• Ability to deal and interact with a wide variety of people at all levels.
• Strong organizational skills.
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international envi-ronment and across functions.
• Ability to mentor and coach.
PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable.
• Minimum 4 - 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance.
• Experience in project management and demonstrated abil-ity to lead work groups in a matrix environment.
• Ability to deal and interact with a wide variety of people at all levels.
• Strong organizational skills.
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international envi-ronment and across functions.
• Ability to mentor and coach.
Additional Information
Experience : 4 - 7 years
Qualification : Pharm.D, M.Sc
Location : Hyderabad
Industry Type : Pharma
Functional Area : Pharmacovigilance
End Date : 25th June, 2018
Experience : 4 - 7 years
Qualification : Pharm.D, M.Sc
Location : Hyderabad
Industry Type : Pharma
Functional Area : Pharmacovigilance
End Date : 25th June, 2018
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