Prakhar Paliwal
Safety and PV Specialist II | Safety Reporting, Regulatory Intelligence | EU Medical Device Regulations and Post Market Surveillance | Pharmacovigilance | Drug Safety
- Role
- Drug Safety Associate at HealthMinds Consulting Pvt. Ltd
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Prakhar Paliwal
Weaving a career that integrates my pharmacy background and expertise in clinical…
Experience
Drug Safety Associate
HealthMinds Consulting Pvt. Ltd
Present
Critically analyses large numbers of articles from biomedical published literature and internal drug safety alerts and identifies individual case safety reports (ICSRs) as well as other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products, as per applicable regulatory requirements and standard operating procedures. Writes brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article. Demonstrates understanding of client’s drug labels and uses that knowledge effectively when performing the safety assessments. Completes drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with the client’s timeliness standards and quality. Uses a drug safety system to track all actions and assessments in an audit-ready reference history. Selects articles specific to the client’s interest for inclusion in the client\'s product literature database per guidelines. Writes accurate, detailed, and complete abstracts of selected articles using good judgment regarding the level of detail required and excellent organization, grammar, and syntax. Extracts key points of articles and creates comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from the client’s database. Ensures timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines. Maintains an awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
Education
Cliniminds
Diploma in Clinical Research and Pharmacovigilance
2017 — 2018
The asian school
Intermediate
2009 — 2011
Department of Pharmaceutical Quality Assurance, GNIPST
Bachelor of Pharmacy
2011 — 2015
Cliniminds India
APGDCRPV (Advance Post Graduate Diploma in Clinical Research and Pharmacovigilance)
2017 — 2018
Gurukula Kangri Vishwavidyalaya
Bachelor's degree
2011 — 2015
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