Pharmacovigilance Services Specialist

Accenture; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A global consultancy is seeking a Pharmacovigilance Services Specialist to manage the preparation and review of PSURs according to standard procedures. The ideal candidate will have a Bachelor of Pharmacy and 7 to 11 years of relevant experience, demonstrating strong skills in client relationship management and safety writing. Responsibilities include stakeholder liaison, data coordination, and ensuring submission readiness of reports. This role is based in Bengaluru, Karnataka, and offers a unique opportunity to contribute to key regulatory processes.

Qualifications

• 7 to 11 years of experience in pharmacovigilance.
• Strong understanding of PSUR preparation.
• Ability to coordinate with various stakeholders.

Responsibilities

• Prepare and review PSURs as per the Client's Standard Operating Procedures and Work Instructions.
• Send the kick-off meeting invite to all contributors.
• Liaise with CLIENT Drug Regulatory Affairs team.
• Coordinate data cleaning process prior to listings generation.
• Perform peer review of draft reports.

Skills

Pharmacovigilance

Client relationship management

Safety writing

Education

Bachelor of Pharmacy

Job description

About The Role

Skill required: Pharmacovigilance Services - Safety Writing

Designation: Pharmacovigilance Services Specialist

Qualifications: Bachelor of Pharmacy

Years of Experience: 7 to 11 years

What would you do?

Prepare and review PSURs as per the Client's Standard Operating Procedures and Work Instructions.

What are we looking for?

Ability to establish strong client relationship.

Roles and Responsibilities

• Prepare and review PSURs as per the Client's Standard Operating Procedures and Work Instructions.
• Send the kick-off meeting (KOM) invite to all the contributors along with agenda, PSUR preparation guide, Previous PSUR, Core Data Sheets (CDSs) or reference safety information, previous PSUR assessment report from HA (if any) and dial-in details.
• Liaise with CLIENT Drug Regulatory Affairs team and request brand names, generic names, country of submission, registration procedure, HA PSUR assessment report (if any), and CDS for reference.
• Liaise with relevant stakeholders for the inputs required for the PSUR.
• Notify the processing team to process relevant cases as per the PSUR schedule.
• Coordinate data cleaning process (missing data clearance and send request for stop/resume book in of cases) prior to final listings generation.
• Schedule meetings with CLIENT safety physicians to resolve report related queries.
• Perform activities as lead author and prepare submission ready draft report.
• Perform peer review of draft reports and provide feedback with the duly filled defect tracker.
• Capture quality data for metrics reporting.
• Completeness and accuracy of source documentation provided by CLIENT for PSUR/AR to be ensured.
• Facilitate Client stakeholders review including QC & QPPV review.
• Shall address all the comments received from all the CLIENT stakeholders including QC reviewer.
• On-time escalation of any delayed inputs.
• Archival of all the PSUR related information in dedicated folders on Client Shared Drives.

Qualification

Bachelor of Pharmacy