Novartis Safety Writer Job Opening 2020 - Apply Online

Novartis Safety Writer Job Opening 2020 – Apply Online

Pharmaceutical Science Jobs. Applications are invited for the post of Safety Writer Aggregate Reporting (AR) @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis. vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com

Job Title: Safety Writer – Aggregate Reporting (AR)

Job ID 304221BR

Minimum requirements

• Graduate/Post Graduate/Doctorate degree in Pharmacy/Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages desirable.
• 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility
• Preferably, at least 2 years of experience in safety/ medical/scientific/regulatory writing
• Excellent understanding of drug development process, GCP and medical terminology
• Strong negotiation and communication skills, and ability to operate effectively in a global environment and across line functions
• Strong organizational and project management skills, with an ability to lead workgroups

Your responsibilities include, but are not limited to:

• Support/lead end-to-end preparation of aggregate safety reports. Support coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
• Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs.
• Ensure a comprehensive and consistent aggregate analysis performed to establish the risk-benefit profile of the product that meets all HA requirements.
• Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
• Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards. Adhere to good documentation practices to ensure audit/inspection readiness.
• Support projects related to operational excellence (including testing of safety systems/IT application) and process improvements according to internal and externals drivers
• Support Health Authority inspections and audits, and the development of Corrective & Preventative Actions (CAPA) to address safety findings. Responsible to be informed with the current global PV regulatory requirements.

See Also
Piramal Research Associate Recruitment 2021 - Apply Online

Job Description

2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate the benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety.

Apply Online

Editors Note: Novartis Safety Writer Job Subscribe to Rasayanika for latest chemistry and Pharma job openings, follow us on Facebook and Whatsapp and subscribe to our youtube channel for latest updates on chemistry and Pharma jobs and much more.

Upload your CV to Rasayanika Talent Pool

LEAVE A REPLY

Please enter your comment!
Please enter your name here