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 : Vigilance Process Expert
Job Description
• Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
• Be involved in the creation and maintenance of 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.
• Support assigned process improvement initiatives including IT projects/systems (leading enhancements 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 compliance to internal requirements. In the case of any delays, investigate the root cause, develop-op and implement corrective and preventative actions. Measure effectiveness of actions taken.
• Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), contribute to the preparation of responses to findings and the development and implementation of corrective 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.
Candidate Profile
• PharmD, MSc degree in life sciences or equivalent.
• Minimum 2 - 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable.
• Experience of leading working groups. Procedural document writing experience
• Strong presentation and communication skills, and ability to operate effectively in an international environment and across Global Line Functions
• Strong organizational skills
• Ability to mentor; Fluency in English. Knowledge of other languages desirable.
Additional Information
Experience : 2 - 4 years
Qualification : PharmD, MSc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 30th July, 2022
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