Executive & Sr. Executive Pharmacovigilance

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

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Qualification

• B.Pharm / M.Pharm

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Experience

• 2 – 4 years of pharmacovigilance experience

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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

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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

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