Unison Pharmaceuticals Walk In Interview 2023. Unison Pharmaceuticals Notification full details below..Interested and eligible candidates can attend interview on scheduled time and venue.Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and most affordable medicines across the nation. With more than 4 decades of medical service to the society, Unison is today one of the fastest growing company in Gujarat State.
Vacancy details:
- Post Name: Sr. Executive – Clinical Research
- Qualification: B.Pharma in Any Specialization/M.Pharma in Any Specialization
- Experienced: 3-7 years
Job Description: Greeting from Unison Pharmaceuticals !!!!!
Important Details :
- Location: Ahmedabad( Moraiya )
- Post of date:24/08/2023
- Selection Process: The selection will be on the basis of Interview.
Opening For Sr. Executive – Clinical Research At Unison Pharmaceuticals, a fast growing global pharmaceutical organisation.
Key Accountabilities/ Responsibilities
Proposing BA/BE study design, Review BA/BE clinical study protocol, CRF, ICF, and report, execution of Clinical phase of BA/BE study for EU/EMB submission study. Monitoring and supervising the conduct of the BA/BE studies at CRO. Preparation PSUR for India market.
Literature Search
- Literature search and review to support the product evaluation/feasibility for generic submission, study design, and identify any BE challenges, possibility Bio-waivers.
- Check for literature update during the conduct of the study
Execution of BA/BE studies
- Develop clinical study design, sample size estimation, blood collection timepoints, additional safety parameters, statistical requirement, washout etc.
- Review and finalization of Protocol and other documents
- NOC/T application
- Plan IPs shipment to CRO, Resolution of IP discrepancy received from CRO
- Execute Monitoring related activities at CRO
- Maintaining and retaining adequate records and reports relating to the clinical study in the sponsors study file.
- Oversee overall exeuction of BA/BE studies at CRO as per agreed timelines and in compliance with standards of GCP and applicable regulations
Review and finalisation of Technical Documents
- Drafting scientific documents for advice from regulatory agency
- Drafting Justification of Biowaiver
- Review and finalisation of Clinical and Non-Clinical overview
- Preparation/review of BE study Summary tables/BTIF for various regulatory Agency
- Drafting Regulatory Query Response
- Review the study results for any abnormal value
- Review and finalization of eCTD report for BA/BE study
- CRO Qualification for BA/BE study
Candidate should have detailed knowledge on:
- Overall conduct of BA/BE studies, Literature search and referencing methodology.
- BA/BE and Clinical study designs, Bio-waiver
- Through knowledge on EMA guidance for Generic submission.
- Exposure in pharmacovigilance activities and preparation of PSUR (Periodic Safety Update Report), RMP (Risk Management Plan) for domestic and emerging market will be preferred.
- Candidate must have Good in written and verbal communications.
Interested candidates may also email their resume to maitrivakil@unisonpharmaceuticals.com
