Senior Manager

ORGANISATIONAL OVERVIEW

JOB DETAILS

Preparation / Review of full PSURs (PBRER format), PADERs, 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.

KEY DELIVERABLES

ALLIED RESPONSIBILITIES

EXPERIENCE

8+ yrs. experience in Pharmacovigilance Aggregate reporting.

EDUCATIONAL QUALIFICATION

COMPETENCIES