Wipro Hiring Drug Safety Specialist
Overview
1. Reviewing the published reports/biomedical literature to ascertain if they contain individual case reports and Non-individual case reports. 2. Applying regulatory and internal guidance to determine if the article meets the definition of a valid case report and Non- individual case reports. 3. Write accurate and concise summaries that capture the key elements from these published reports 4. Ensure consistent coding of medical history, drugs and adverse event terms 5. Evaluation of Serious Adverse Event to ensure accurate processing from source documents with emphasis on quality and timeliness 6. Creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing) to support the drug safety reporting and information requirements of pharma industry client |
Qualifications
M.Pharm / B.Pharma / BAMS / BHMS / PhD./ Pharm D / BDS |
Mandatory Skills
1) Sound knwoledge of regulatory guidelines related to PV domain 2) Narrative Writing 3) MedDRA Coding 4) Familiarity with pharmacological concepts 5) Command on verbal and written communication skills 6) Team Player |
Dear Recruiter,
Greetings for the day!!
I am very much interested in applying for the position you advertised
on socila media recently. My educational qualifications and experience of 4.6 Years in
ICSR case processing match the required job specifications. I would
appreciate it if I am given a chance to prove my value addition for
this job role.
Kindly find attached my resume. It would be a pleasure to discuss this
exciting opportunity with you. Looking forward to making this work.
Thank you.
Best Regards,
Ramesh Mungalla