Pharmacovigilance Services Analyst

Accenture; Chennai District; On-site; INR 600,000 - 900,000; Full time

Job summary

Accenture seeks a Pharmacovigilance Services Analyst to join its safety operations in Chennai. You will manage case creation in global safety databases, perform triage and data entry, and support timely regulatory submissions.

The role requires a Life Sciences degree, proficiency in MedDRA/WHODD, and strong medical writing and English skills. You will work within a fast-paced team, ensuring adherence to SOPs and client guidelines while maintaining data quality and timeliness for adverse event

Qualifications

• Bachelor's degree in Life Sciences.
• Experience with MS Office and safety databases.
• Knowledge of MedDRA/WHO-Drug terminology.
• Strong medical writing and communication skills.
• Excellent English language proficiency and quick learning ability.

Responsibilities

• Identify and create cases in the global safety database from intake sources in compliance with SOPs and regulatory requirements.
• Triage, data entry and processing of serious and non-serious cases per client guidelines and regulations.
• Perform AE collection, evaluation, transmission, reconciliation, and coding per SOPs.
• Review source documents for validity, perform duplicate checks, and escalate as needed.
• Draft narratives and ensure timely case processing and regulatory reporting.

Skills

MS Office

Medical writing

Communication skills

English language

Education

Bachelor's Degree in Life Sciences

Tools

Safety database

MedDRA/WHO-Drug

Job description

Skill required:

Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

Designation:

Pharmacovigilance Services Analyst

Qualifications:

Any Graduation

Years of Experience:

3 to 5 years

About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com

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 ICSSs 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. Any Graduation

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