Quality Assurance Analyst Junior jobs in Gurgaon at Caretel Infotech Ltd

PV Quality Systems

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).
With regards to third party agreements ? Perform due diligence. ? Perform reconciliation of data between the third party and client.
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.