Medical Safety Expert Jobs India | MBBS Jobs In India 2021 -

Medical Safety Expert Jobs India | MBBS Jobs In India 2021

India – Novartis is looking to hire following staff.

Medical Safety Expert Jobs India | MBBS Jobs In India 2021

About Novartis:
769 million lives were touched by Novartis medicines in 2020, 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.

1- Medical Safety Expert
Full Time
Hyderabad, India

Job Responsibilities:
A- Provide rotating support to the TAs according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries
B- Assist the TA Safety Leads in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. Medical review of single case reports will be performed by associates possessing medical degree.
C- Perform Literature review for PSUR inclusion and assessment of literature for ICSRs. Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests.
D– Together with the Safety Leads, co-author the PSUR, in particular provide medical inputs to sections 15, 16, 17, 18, including analytical input to PSUR for known and potential risks defined in the RMP. Perform follow up activities on Health Authority Assessment Reports.
E– Assist in providing safety input to Regulatory Affairs and clinical documents (for CDS and IB RSI), Support maintenance and management of local deviations (SMPC, USPI, Japanese PI). Assist in evaluating and writing other safety deliverables including but not limited to clinical overviews, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR).

Job Requirements:
A- MBBS or MD is required.
B- Good knowledge/fluency in English. Knowledge of other languages desirable
C- May be a first job in the pharmaceutical industry for an MD with 3 or more years of clinical experience after graduating from medical school
D– Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
E– Excellent understanding of clinical trial methodology, GCP and medical terminology. Attention to detail and quality focused
F– Strong organizational and project management skills. Strong negotiation and communication skills, and the ability to operate effectively in an international environment

Last Date to Apply: Until The Vacancy is Filled

Novartis Jobs – India

TitleMedical Safety Expert Jobs India | MBBS Jobs In India 2021
Hiring OrganizationNovartis
Job LocationHyderabad, India
Date PostedSep/25/2021
Base SalaryINR
DescriptionListed below
Employment TypeFull Time
Valid UntilSep/30/2021
Medical Safety Expert Jobs India MBBS Jobs India 2021
Medical Safety Expert Jobs India MBBS Jobs India 2021

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*This Jobs was Originally Posted on Novartis Careers Site..

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