Loading Jobslly...
Role & Responsibilities
Author and support aggregate safety reports including PSURs, PBRERs, RMPs and Addendums
Perform ICSR data entry, processing and management in global safety databases
Conduct literature searches for individual case safety reports and periodic reports
Ensure compliance with internal SOPs and global pharmacovigilance regulations
Coordinate with global affiliates and cross-functional stakeholders
Support safety signal detection and ongoing risk management activities
Qualification
B.Pharm / M.Pharm
Experience
2 – 4 years of pharmacovigilance experience
Skills
PSUR, PBRER, RMP and AddCo authoring
ICSR case processing and literature review
Knowledge of ICH, GVP, US FDA and EMA guidelines
Scientific writing and documentation
Attention to detail and time management
Strong communication and problem-solving abilities
About the Company
Mega Lifesciences is a global healthcare and pharmaceutical organisation delivering evidence-based medicines and operating robust pharmacovigilance systems to ensure patient safety and regulatory compliance across international markets