Pharmacovigilance Services Analyst

Skill required: Pharmacovigilance Operations - Pharmacovigilance Drug Safety Surveillance

Designation: Pharmacovigilance Services Analyst

Qualifications:Any Graduation

Years of Experience:3 to 5 years

Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song- all powered by the world-s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries.

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

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).

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 req


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.


Qualification
Any Graduation