Novartis hiring D Pharma Candidates – Process Expert Post
Novartis hiring Vigilance Process Expert. D Pharma job opening 2022, Pharmacy job opening 2022, Pharma job opening 2022. D Pharma job opening 2022. Pharmacy expert job, exper job opening 2022. Intrested and eligible candidates may check out all the details on the same below:
Job Id: 348189BR
Job Title: Vigilance Process Expert
PharmD, MSc degree in life sciences or equivalent.
Experience & Skills
Minimum 2 – 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance is 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 is desirable.
Your responsibilities include, but are not limited to:
• 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 complianceto global regulatory requirements.
• Support assigned process improvement initiatives, including IT projects/systems (leading enhancements and managing releases). Analyze the impact of other processes and organizational changes.
• Work in collaboration with the Compliance & Quality function to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements. In case of delays, investigate the root cause and develop 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 preparing responses to findings, and develop and implement 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.
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