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Medical Safety Writer(Aggregate report writing- PSUR,PBRER)


Job Description
2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate 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.
Your responsibilities include, but are not limited to:
. Lead preparation of global periodic safety reports for newly launched products. Lead coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
. Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards
. Support in creating strategy for data analyses and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs.
. Support in the development of safety document templates and Standard Operating Procedures pertaining safety aggregate reports
. Contribute to global projects focusing on process & quality improvement initiatives. Contribute as subject matter expert during Health Authorities inspections/audits and contribute in development, implementation of appropriate Corrective and Preventative Actions (CAPA).
. Train and mentor new CMO&PS associates and associates from other line functions on medical safety writing & periodic reporting matters.
. Support Head, Safety Report Writing/Head, Aggregate reports and assist with the recruitment of new staff.
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Minimum requirements
. Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Fluency in English.
. Knowledge of other languages desirable. 4 to 8 years' experience in drug safety/ development or closely related areas of responsibility, with a minimum of 3 years' experience in in safety/ medical/scientific/regulatory writing preferably, at least 2 years of experience in safety writing
. Sound expertise in data analysis and presentation Strong project management and communication skills. Ability to lead global and cross-functional work groups excellent understanding of drug development.
Why Novartis
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Posted
06/23/2022
Location
secunderabad, TG, IN