Novartis Pharma Compliance Excellence Expert – Apply Online
Novartis invited candidates with a D Pharma degree for the post of Vigilance Compliance Excellence Expert. Pharma job opening 2021. Pharmacy job 2021. Vigilance Compliance Excellence Expert job opening 2021. Pharma job opening 2021. Pharmacy job 2021. Check out all the details on rasayanika.
Job Title: Vigilance Compliance Excellence Expert
Job ID 328765BR
Eligibility Criteria:
• PharmD, MSc degree in life sciences or equivalent. Fluency in English.
• Knowledge of other languages desirable.
• 2 to 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance Procedural document/ report writing experience
• Good analytical skills / proven ability to work with data
• Good communication and presentation skills
• Good organizational skills
• Ability to mentor and coach
Your responsibilities include, but are not limited to:
• To support the management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products
• Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient-Oriented Programs (POP), registries and all Spontaneous Reports (SR).
• Transcribe, translate (where required) and
enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.• Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications, etc in cooperation with other departments
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
• Work with other local/global PV associates to ensure accurate evaluation of safety data. Interact and exchange relevant safety information with LHA, PV associates, other functional groups, and third-party contractors, if applicable.
• Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide updates to global PVO organizations.
• Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
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