Nitasha Thakur
Intern - Medical Writer, Patient Safety | Aspiring Pharmacovigilance & Clinical Research Professional | Focused on Drug Safety, Global Safety Regulations & Evidence Based Practices
- Role
- Intern Medical Writer Patient Safety at Parexel
- Location
- Kangra, HP, IN
- LinkedIn followers
- 500 followers
About Nitasha Thakur
As a Master\'s student in Pharmacovigilance and Clinical Research, I\'m passionate about ensuring drug safety and advancing public health. With a strong foundation in- Adverse Event Reporting, End to End ICSR processing & Narrative writing-Familiar with Working on Safety Database -Signal detection, Risk Management - Aggregate reporting (PSUR, PBRER)- CRF, Protocol design and development - Regulatory guidelines (ICH, GCP, GVP, CIOMS, WHO)- MedDRA coding and WHO-DDI\'m committed to making a meaningful impact in drug safety, efficacy, and public health. My passion for pharmacovigilance and clinical research drives my pursuit of innovative solutions, evidence-based treatments, and enhanced public health outcomes.
Experience
Intern Medical Writer Patient Safety
Jan 2026 — Present · Hyderabad, IN
Preparation of PSRs including PBRER\'s, DSUR\'s, PADER\'s, ACO\'s, SASR\'s amd checking of international Non- proprietary Names (INNs) for inclusion in PSR in accordance with client requirements/conventions and SOPs. Maintaining liasion with relevant client personnel for obtaining contribution for different sections of the PSR, for raising and resolving doubts and discrepancies in the data and for coordinating review of the report. Awareness of international drug safety regulations including ICH guidelines, GVP guidelines, FDA guidelines and CIOMS and MedDRA coding in accordance with \" MedDRA Term Selection: Points to consider\". Performing quality check of PSRs. Organizing workload to ensure compliance with internal and regulatory timeline. Handling other activities associated with PSRs, such as PSR submission, National appendices creation, Safety statement preparation, Comparison of local and global labeling documents, Regional DSUR appendices preparation, Post-marketing patient exposure calculation.
Education
Chitkara University, Punjab
Master's degree, Pharmacovigilance and Clinical Research
Himachal Pradesh Technical University (HPTU)
Bachelor's degree, Pharmacy
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