ASSISTANT GENERAL MANAGER/DEPUTY GENERAL MANAGER-MEDICAL AFFAIRS Hetero

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As a Medical Monitor, your primary responsibilities will include: - Monitoring the in-house clinical trials and overseeing CRO medical monitoring of outsourced projects - Developing and reviewing clinical documents such as protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions, etc. - Organizing Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Your secondary responsibilities will involve: - Reviewing Medical Review of ICSRs, Aggregate reports, Signal reports, and Risk Management plans - Reviewing clinical and non-clinical overviews and summaries of CTD - Reviewing medi...

Posted 1 month ago

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Safety Writer Fortrea

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. You will perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussions for comment resolution. Additionally, you will write various safety ...

Posted 3 months ago

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