Ind-Swift Ltd – Hiring for Clinical Research Department

Ind-Swift Limited – Jawaharpur, Derabassi is the Ace unit of Ind-Swift Limited, was created in the year 2005 with an aim to globalize the Ind-Swift brand for finished dosage forms. We are a 100% Export Oriented Unit dealing in regulated markets having approval like MHRA, TGA & GLC etc. 

 

Attention all pharmaceutical professionals! We are currently hiring Officer / Sr. Officer in Clinical Research department at Ind-Swift Limited (GBU) 100% EOU (OSD Formulation Site), Derabassi, Distt-Mohali.

Job Description:

• Qualification:- B.Pharm / M.Pharm
• Experience:- 03 to 05 years (in Clinical Trial / Medical writer / scientific writer / Clinical research from CRO / Pharma company)
  Location:- Panchkula (Haryana)

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Job Responsibilities:

1. Literature search, review and preparation of Clinical (module 5.1, 5.2, 5.3, 5.4, 2.5, 2.7, 2.2) and non-clinical (module 4.1. 4.2, 4.3, 2.4, 2.6) modules.
2. Preparation PI / SPC / PIL and other scientific documents & filing of BE Application Form.
3. Timely updation of PI/SPC/PIL and handling of query on same (if any) and their response
4. Review of BE study documents (protocol, CRF, ICF) and maintain of all records related to internal and external communications with CROs for BE studies.
5. Pharmacovigilance (PV) related activity ex. Preparation of PSUR (periodic safety update report) and RMP (risk management plan), review of safety data exchange agreement and maintain record as per the requirement.
6. Maintain of record of report adverse events related to product complaints and their response in file.
7. Compilation and submission of documents for T license, bio T-license and BE NOC for BA/BE studies.
8. Preparation of SOP for Clinical and PV activities and their updation.
9. Handing of query related to RA dossier on modules and scientific documents.

 

How to Apply:

• If you are interested in joining our team, please send your CV at hr.gbu@indswiftlabs.com or WhatsApp on +91-8360051452.
• We look forward to reviewing your application and potentially welcoming you to our team.

 

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