Quality Assurance Analyst Junior
Caretel Infotech Ltd
0 - 3 Years
|
Confidential
|
Gurgaon
Caretel is part of Dalmia group (A leading Indian company conglomerate with GHCL, as a flagship company). The group has diverse business interest including Chemicals, Telecom, IT Enabled Services, Tobacco, Explosives, Dairy products, Textiles, Resorts and many others. Caretel was incorporated in year 2004 and since then providing its services to various clients . As part of its expansion strategy, the company has focused into the area of Multimedia Contact Centers including Business Process Outsourcing. Caretel has achieved substantial success in the domestic market by acquiring major multi-national clients in the Automobile, White Goods, FMCG, IT, Telecom, Entertainment, E governance ,Finance and Insurance sectors. Some of the key clients amongst an impressive list of over 60 major corporations.
Website: www.caretelindia.com
Profile Offered: Quality Assurance Analyst Junior
Job location: Gurgaon
Course Specialization: ME/M.Tech, M.Com, BSc, BCA, BE/B.Tech, PG Diploma, MSc, Diploma, B.Com, MCA
Desired Experience: 0 - 3 Years
Roles and Responsibilities:
To comply with the client Pharmacovigilance Quality systems and policies.
Ensure compliance with procedures for document management retention and archiving.
Ensure all training requirements for the role are met.
Ensure adherence to the BCP (Business Continuity Plan).
Case Intake o Manage the receipt and capture process for adverse event (AE) and pregnancy report collection in the Pharmacovigilance safety database.
Various sources of AEs include but are not limited to; spontaneously reported cases from patients, HCP, nurses, client employees (including AEs associated with product complaints and AEs associated with medical queries),social media reports, partner companies and regulatory authorities; and solicited cases from patient support programs, market research programs, clinical studies and call centers.
Assess the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database.
Perform the initial assessment on case validity, check for core case elements, perform duplicate checks and request for case deletion as required.
Perform a seriousness assessment and assess expectedness against the local label.
Perform translation of source documents and local quality check of translation as required. Ensure all source documents are captured in the Pharmacovigilance safety database.
Determine the requirement for follow up information and collect as much information related to a particular ICSR.
Manage the process for collection and handling queries from the Global team.
Re-assess the follow up information in the context of case validity, seriousness and expectedness; capture all follow up information and source documents in the Pharmacovigilance safety database.
Perform ongoing tracking and local quality check of AE cases for follow up and submission requirements.
Education:
B.Com., B.Sc., B.Tech/B.E., BCA, M.Sc., M.Tech./M.E., MCA
Work Experience:
0 - 3 Years
Salary
Confidential
Industry
IT
