Hiring For One of the TOP IT MNC for Mumbai | Medical Reviewer | Medical Writing | Call - Shubhani
Job World
Mumbai, MaharashtraNavi Mumbai, Maharashtra
Permanent
Full-time
22 days ago
Hello Greetings !! Mega Openings for one of the top multinational firm for Medical Reviewer & Medical Writing. Band - 2/3/4/5 Salary Upto- 24LPA + NSA Both side Cabs / 5 Days working / 2 Rotational Offs / Other Perks and Benefits Candidate must be comfortable with 24*7 . Any Graduate / Post Graduate Can apply. Call @ WhatsApp - Shubhani - 8130948377 1- Role -Medical Reviewer. Qualification: MBBS/MD only (MCI Certification is not mandate**) Grade: BPO 4/5 Experience Range: 1 to 7 Years Preferred Experience: Minimum of 1-5 years of experience in PV/ Clinical Research (drug safety) Location: Mumbai/ Pune/ Nagpur/ Gandhinagar/ Bangalore/ Chennai/ Indore. Basic Job Description:- Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR) Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. 2-Role -Regulatory Medical Writer. Experience 4 - 11 years of experience in Medical Writing domain. Location: - Mumbai, Pune, Bangalore, Noida Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. 1. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. 2. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. 3. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. 4. Share project timelines amongst the study team for the development of document. 5. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. 6. Review statistical analysis plans and table/figure/listing, when required. 7. Ensure uniformity and consistency in the scientific content of the regulatory documents. We have an urgent requirements kindly pass this with your friends and colleagues Follow Us on these Pages for the PAN INDIA Openings ALERTS!!!! For More Information kindly share your Updated resume on this undermentioned number. Call @ WhatsApp - Shubhani - 8130948377 WhatsApp -https://whatsapp.com/channel/0029Va7q1m3AInPrc9h6VQ0w Facebook -https://www.facebook.com/profile.phpid=61552833483482&mibextid=ZbWKwL LinkedIn - https://www.linkedin.com/in/kajal-gupta-025929142 Thanks And Regards Shubhani WFM