JOB DETAILS

JOB DETAILJob Details

Pharmacovigilance (PV):
Ensure compliance with local/global safety regulations.
Process and report safety events (pre- and post-marketing) to global PV and local authorities.
Conduct literature screening and safety data reconciliation.
Support RMP, PSMF, PV training, and inspections/audits.
Regulatory Affairs:
Prepare and maintain registration dossiers and product licenses.
Assess regulatory impact of product changes and label updates.
Provide regulatory intelligence and support local strategy implementation.
Maintain local label database.
Quality Assurance:
Support GDP inspections and self-audits.
Handle product complaints and deviations.
Update SOPs and manage compliance records.
Oversee product import/release and vendor audits.
Review promotional materials.

REQUIRED WORK EXPERIENCERequired

✓Bachelor’s Degree in Pharmacy, Life Sciences, or a related field
✓1 – 2 years of experience in regulatory affairs role in pharmaceutical industry would be an advantage
✓Strong analytical and problem-solving skills with the ability to interpret complex regulatory requirements
✓Strong organizational and process management skills.
✓Proactive, detail-oriented, and able to multi-task effectively.
✓Flexible and adaptable to a dynamic regulatory environment.
✓Able to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
✓Teamwork and collaboration with cross functional teams
✓Who　has a car