Adithya Madhu Nair
Summary
A highly skilled, systematic, and detail-oriented Pharmacovigilance expert with at least one year of experience leading in pharmacovigilance processes/operations. Expertise in the whole RMP process, including management and evaluation of various PSRs. Well-versed in formulation and production, quality compliance assessments, and regulatory submission document evaluation. Skilled in assisting senior management with resourcing and process development tasks such as document evaluation updating, and review, defining reporting needs, and template coding norms.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Safety Project Manager-Intern [Full-time Employee]
Merck Specialties Pvt Ltd
11.2022 - Current
- Process Management & Risk assessment of all PSRs.
- Performed Quality review of Regulatory Reports (PSRs) to identify deficiencies and recommend CAPA.
- Developed and implemented Quality Control checklist as standard reference for quality review of various PSRs
- Scheduled and tracked deadlines of multiple active compliance audits and assisted in maintaining internal access databases for document archival to EDMS.
- Maintained organized and efficient document flows by using excellent planning and multitasking skills for internal team members, medical writers, authors or client specifications.
Assistant Pharmacist
Messia Pharmacy
06.2020 - 07.2022
- Managed inventory of medications and other supplies, Developed and implemented patient counseling protocols to enhance medication adherence
Project Trainee
Sai Mirra Innopharm Pvt Ltd
11.2021 - 04.2022
- Submission of project entitled 'Formulation, Development and Evaluation of Diclofenac Potassium Buffered tablets - An Anti-migraine agent'.
Trainee
Glenmark Pharmaceuticals Pvt Ltd
06.2019 - 07.2019
- Developed and implemented new processes that improved operational efficiency and reduced customer wait times by 60%
Education
Master of Pharmacy - Pharmaceutics
JSS College of Pharmacy
Ooty, Tamil Nadu05.2022
PG Diploma - Regulatory Affairs
JSS College of Pharmacy
05.2022
Bachelor of Pharmacy -
JSS College of Pharmacy
Ooty, Tamil Nadu05.2020
Skills
- Process Management & CAPA Recommendations
- Quality Review of Regulatory Reports (PSRs) for Compliance
- QC Process Validation & Document Archival
- AMA Standards & Cross-Functional Collaboration
- Interpersonal Skills, Process Redesign, Timely Management
Permanent Address
Viswabhavan, Kidangara PO
Alappuzha Dist, Kerala
India - 686102
Languages
English
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
Kannada
Intermediate (B1)
Tamil
Upper intermediate (B2)
Malayalam
Bilingual or Proficient (C2)
Certification
- Licensed Pharmacist - Kerala State Pharmacy Council (Reg No: 76031)
Accomplishments
- BRD4 as Breast cancer target protein - A comprehensive review on therapeutic agents, IJPPR dated Apr 2022
Marital Status
Unmarried
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Opportunities Don't happen.You create them.
Chris Grosser
Timeline
Safety Project Manager-Intern [Full-time Employee]
Merck Specialties Pvt Ltd
11.2022 - Current
Project Trainee
Sai Mirra Innopharm Pvt Ltd
11.2021 - 04.2022
Assistant Pharmacist
Messia Pharmacy
06.2020 - 07.2022
Trainee
Glenmark Pharmaceuticals Pvt Ltd
06.2019 - 07.2019
Master of Pharmacy - Pharmaceutics
JSS College of Pharmacy
PG Diploma - Regulatory Affairs
JSS College of Pharmacy
Bachelor of Pharmacy -
JSS College of Pharmacy
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