Senior Executive / Assistant Manager - Aggregate report

Job Description for Aggregate Report Writing

Job Profile: Aggregate Report Writing (PSUR) and quality check

Experience : Minimum 3 to 5 years of PSUR Writing/quality check

Job Position : Senior Executive / Assistant manager

Reporting to Group Leader - Aggregate Report

Job Description:

• Preparation / Review of full PSURs (PBRER format), Addendum to Clinical overview summary report, and Annual Summary Report as per GVP and / ICH guidelines
• To evaluate the effectiveness of implemented educational materials for additional risk minimization measures and additional PV activities
• Safety data analysis from line listing generated from Pharmacovigilance database for signal and risk evaluation
• Review of published literature for new significant safety information,
• Review of safety data reported from clinical/non-clinical studies and safety variations
• Awareness of MedDRA coding and its terminologies
• Through awareness of good pharmacovigilance guidelines for EU, Non-EU, and other and RoW countries
• To ensure pharmacovigilance activities are carried out in accordance with company SOPs and applicable regulations / guidelines.
• To provide support to other members of the pharmacovigilance team as required
• To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues
• Assist in the development of appropriate standard operating procedures.
• Any other tasks as requested as by line manager to meet the business requirements.