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.
[caption id="attachment_66233" align="aligncenter" width="1200"]
Pharmacovigilance Professionals Wanted at Novumgen Pvt Ltd, Vadodara[/caption]
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!
https://pharmastuff.org.in/job/pharmacovigilance-professionals-novumgen-vadodar?feed_id=4125
