Clinexel Life Sciences Released Job Openings On 27/09/2022.CLINEXEL is a full-service Clinical Research Organization. We provide clinical research, clinical development, regulatory affairs, medical writing and pharmacovigilance services. Our Clients include companies with their innovations (new chemical entities & biologicals) in early clinical development phase, small/ mid-size pharma and biotechnology companies with niche products and medical device companies focused on complying with new EU Medical Device Regulations.
Vacancy Details:
Clinexel Life Sciences Recruiting B.Pharm/ M. Pharm/ M. Sc Graduate with 03-05 years experience for Pharmacovigilance, Medical Writing, QA, CRA, CDM and Bostatisics Position.
Important Details :
- Location : Mumbai
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 27/09/2022
- Mode of application :Online
- How To Apply: Kindly share your resume at careers@clinexel.com
Related Job: Tata Consultancy Services(TCS) Hiring B.Pharm,M.Pharm In Pharmacovigilance
Job Description/Skills Required
These are office-based positions, at The Affaires Palm Beach Road Navi Mumbai. Kindly share your resume at careers@clinexel.com All queries to marked to the same email.
1. Sr Executive/ Manager in #QualityAssurance & Training department, to facilitate various activities of the department- SOP management, #NC#CAPA documentation, conduct vendor audits, participate in client #audits , management of Training calendar, training files and training documentation.
· Desirable Qualification- B.Pharm/ M. Pharm/ M. Sc
· 3-5 years of industry experience in quality assurance in Clinical Trials or/ and #Pharmacovigilance.
· Good knowledge of #GCP, #GVP
· Well versed with #regulations
2. CRA/ Sr CRAs for #ClinicalResearch Department: conduct site qualification visits and #monitoringvisits, to train and guide site staff in the protocol and trial procedures, safety reporting, proactive use of EDC and other data source systems for preparation and conduct of site visits as well as SDV, coordinate with #datamanagement for query resolution, ensuring trial supplies, Collect and management of essential documents,
· Desirable Qualification- B.Pharm/ M. Pharm/ Pharm D
· 2- 4 years of industry experience, experience in Phase 2 and 3 clinical trials preferred
· Good knowledge of GCP and NDCTR
3. Manager in #ClinicalDataManagement & #Biostatistics department- 4 – 6 years of experience in clinical research industry, experience in study set-up phase and data analysis phase, eCRF design, subject diary inputs, edit checks, UAT, external data load, data validation activities during conduct and database lock, data review, query management, external data load review, query management, SAE reconciliation, creating data listings and reports. Candidates with good knowledge of GCP /#GDMP and experience in Oncology Phase II/ III trials will be preferred
4. Medical and Safety Writers- 3- 5 years of experience in #medicalwriting and/ or #safetywriting, and preparation of essential documents for clinical trials. Scientific background with writing experience in multiple therapeutic areas. Demonstrated understanding of #clinicalresearch, #pharmacovigilance, drug development process, guidelines and regulations. Min qualification- postgraduation
5. Drug Safety Associates in #Pharmacovigilance Department:- with 2-5 years of industry experience in various #pharmacovigilance activities, including #caseprocessing, preparing #periodicreports, #literaturemonitoring and #signalprocessing. Understanding of #GVPmodules and various #PVregulations. Pharmacist/ dentists/ doctors of alternate medicine preferred
These are office-based positions, from #CLINEXEL office on Palm Beach Road, Sanpada, Navi Mumbai.
If you are interested in being part of a high performing team working on high quality projects, please share your resume at careers@clinexel-cro.com
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