Life Science ServicesPharmacovigilence Representative
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Overall Purpose of the job
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.
Responsibilities/Authorities
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.
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.
Review responses to queries when received and add any follow-up information to the case narrative and other fields as required.
Review and perform the case correction case deletions of the relevant cases as per SOPs and the guidance provided by the Client within the applicable timeline.
Archive all communications/clarifications related to the Case in the Global Safety Database.
Escalate issues or tasks outside the normal scope of work to the respective lead. If team lead is unavailable escalate to service delivery lead/operations lead.
Open to get trained and moved across roles based on business requirement.
Successfully complete and clear all applicable training within required timelines.
To perform assist and contribute to transition related activities as per the client requirement.
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.
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.
Responsibilities/Authorities
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.
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.
Review responses to queries when received and add any follow-up information to the case narrative and other fields as required.
Review and perform the case correction case deletions of the relevant cases as per SOPs and the guidance provided by the Client within the applicable timeline.
Archive all communications/clarifications related to the Case in the Global Safety Database.
Escalate issues or tasks outside the normal scope of work to the respective lead. If team lead is unavailable escalate to service delivery lead/operations lead.
Open to get trained and moved across roles based on business requirement.
Successfully complete and clear all applicable training within required timelines.
To perform assist and contribute to transition related activities as per the client requirement.
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.
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).
Shift timing : 6 am - 3 pm & 3 pm - 12 am
Work mode : Work from office
Key Skills
- Environment
- Anatomy
- Fisheries
- Morphology
- Behavioural Sciences
- Biophysics
- Evolution
- Forestry
- Ecology
- Biotechnology
- Agriculture
- Biochemistry
- Biology
- Ecosyatem
- Entomology
