Pharmacovigilance Professionals Wanted at Novumgen Pvt Ltd, Vadodara

Novumgen Pvt. Ltd. is hiring pharmacovigilance professionals for their department in Vadodara. Responsibilities include SOP development, signal management, aggregate reporting, ICSR activities, and more. Apply now!

Organization: Novumgen Pvt Ltd

Work Location: Vadodara (Corporate Office)

Department: Pharmacovigilance

Job Description:

• Develop and implement Standard Operating Procedures (SOPs) for Pharmacovigilance activities.
• Review and conduct signal management activities in accordance with guidelines and SOPs.
• Prepare, review, and report aggregate reports such as PADER, PBRER, and PSUR as per regulatory requirements and compliance with guidelines and SOPs.
• Oversee in-house and outsourced pharmacovigilance (PV) activities and maintain monthly compliance processes.
• Ensure compliance with quality, procedures, regulations, timeliness, and consistency for aggregate reports, signal management, and all EU activities.
• Facilitate safety monitoring by optimizing scientific quality documentation and entering safety case reports, including spontaneous litigation reports.
• Manage Individual Case Safety Report (ICSR) activities as per regulatory requirements, ensuring safety data accuracy in safety databases.
• Conduct partner/vendor audits and communication for all PV activities.
• Prepare and review Safety Data Exchange Agreements (SDEA).
• Handle risk management plan (RMP) programs in line with innovator guidelines for the UK and EMA.
• Manage XEVMPD and SPOR databases, ensuring timely updates for safety variations as per Art. 57 guidelines.

How to Apply:

Exciting news! If you’re interested, you can send your most recent CV to the wonderful Isha Patel at isha.patel@novumgen.uk. Don’t miss out on this fantastic opportunity!