Job
Description
Skill required: Pharmacovigilance Operations - Pharmacovigilance Drug Safety Surveillance
Designation: Pharmacovigilance Services New Associate
Qualifications:Bachelor of Pharmacy/BSc. Nursing/Bachelor Degree in Life Sciences
Years of Experience:0 to 1 years
What would you do
Responsible for identification and creation of cases in the Global safety database from the reports received via intake workflow, client mailbox, electronic gateway, and other sources (as applicable). Responsible for retrieving new incoming safety information or follow-up correspondence for existing cases in compliance with client standard operating procedures (SOP) and global regulatory requirements.Responsible for triage, case prioritization, data entry, case processing, submission and follow up (as applicable) of serious and non-serious cases in the core safety database as per Client guidelines and global regulatory requirements.
What are we looking for
Educational and Experience Requirements:
Bachelors Degree in Life Sciences Technology skills:experience with MS office, knowledge of safety database Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug preferred.Good medical writing skills Good Communication Skills Strong English Language proficiency (Reading, Writing, Listening and Speaking).Key performance indicators:Ability to learn quickly.Consistent demonstration of company values/behaviors.Adverse events are evaluated accurately, and cases are processed within the required timeframes to meet regulatory requirements.Process cases with good quality metrics.Performs all work in accordance with all established regulatory and compliance and safety requirements.Assisting with tracking, submitting and distributing of reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and participating in audits and inspections.Validate data consistency and make any corrections as needed.Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Client SOP.Check for any pending action items, follow-up, clarification, corrections and ensures resolution and close the action items for the case.Perform submissions in global safety database for all the AEs, SAEs and SUSAR cases as per Client SOP, to Monitor submission related client reports and trouble shoot submission issues if any.Perform translations of source document, case narrative, adverse events as applicable. Monitoring, tracking and reconciliation of client mailboxes and other sources as applicable.To perform paper and electronic unblinding process if required as per Client SOP
Roles and Responsibilities: Prioritise, book in, triage, and case processing activities for ICSRs in accordance with Client Guidelines, Regulatory due date, and TAT SLAs and KPIs. The case processing activity includes end to end case processing as per the agreed client requirement and case processing guidelines.Prioritize the cases from Intake workflow, mails and other sources to create cases in global safety database, identify, review for validity of cases and move the cases to respective workflow step based on case type as per the defined timelines.To perform collection, evaluation, and submission of Adverse Event (AE) reports, transmission, and reconciliation of pharmacovigilance data of individual case reports. This includes but is not limited TMF (Trial Master File) review download of AE reports from EVWEB and the MHRA portal and the importing of AE reports on the pharmacovigilance database. Review the source documents (SD) for validity of ICSR, perform duplicate check in the intake workflow/safety database and confirm whether the information is medically significant or relevant and takes necessary actions in accordance with Client SOPs.Request for missing minimum safety Information or clarification of erroneous data if needed and sent queries in accordance with Client SOP, guidelines from the Marketing company (MC) or reporter as applicable.Complete the case processing of safety information, including but not limited to coding of relevant medical history, suspect drug, adverse event and draft narrative into the applicable Global Safety Database from the available source documents.Assess adverse events for seriousness, causality as per applicable Client SOPs, consulting the medical reviewer or medical validator whenever needed.Perform medical coding/Drug Coding for each ICSR in accordance with Client Guidelines and SOPs using MedDRA and WHODD.Complete and review the evaluation of the case including reporter/company causality, prepare the narrative section and E2B senders comment field as per Client SOP.Processing all the AEs, SAEs and SUSARs in the Global Safety Database according to the applicable company policies and Standard Operating Procedures (SOPs).Other essential duties include drafting pharmacovigilance agendas and meeting minutes; accurately archiving pharmacovigilance documents; reviewing safety case data and other pharmacovigilance documents for completeness and accuracy.
Qualification Bachelor of Pharmacy,BSc. Nursing,Bachelor Degree in Life Sciences
