Precision in Safety: Novotech Bangalore Hiring Pharmacovigilance Specialist

Novotech, a global leader in clinical development and ISO-certified CRO, is looking for a skilled Pharmacovigilance Associate to join its team in Bangalore. As an organization that holds ISO 27001 and ISO 9001 certifications, Novotech is committed to maintaining the highest IT security and quality standards for patients and biotechnology partners worldwide.

Core Specialization: DSUR Expertise

The hallmark of this role is the preparation of high-level safety reports. Candidates must have direct experience in writing and preparing Development Safety Update Reports (DSUR) to be considered for this position.

Key Responsibilities

The PV Specialist ensures that clinical trial safety data is handled with meticulous accuracy according to ICH-GCP and global regulatory standards.

System & Database Management: Support the setup of safety databases such as ARGUS, ARISg, and CRSCube.
Case Processing: Manage adverse event reporting and conduct quality control of all PV activities to ensure data integrity.
Regulatory Reporting: Review annual safety reports and handle expedited or periodic reporting to regulatory authorities, investigators, and IRBs.
Aggregate Reports: Prepare periodic aggregate reports, including PSUR, PBRER, and DSUR, along with comprehensive Risk Management Plans (RMP).
Post-Marketing Support: Conduct literature searches and case handling for post-marketing services in compliance with regulatory timelines.

Candidate Profile & Eligibility

Novotech is seeking candidates with a strong clinical background and integrated information-collection capabilities.

Criteria	Requirements
Education	Bachelor’s in Pharmacy, Nursing, Medicine, or Biology. (Master’s/PhD preferred).
Experience	2+ years for Associate level; 4+ years for Senior positions.
Core Requirement	Mandatory experience in DSUR Writing/Preparation.
Skills	Knowledge of MedDRA coding, GCP, and clinical medicine is essential.
Tools	Proficiency in MS Office and global safety databases.

Why Bangalore at Novotech?

Joining the Bangalore office puts you at the heart of Novotech’s clinical development services. You will work in a fast-paced environment that values information security and quality excellence, helping to provide pioneering solutions to the biotechnology sector.

Application Deadline: May 15, 2026