· Education MBBS/MD
· Minimum 2-3 years of experience in Pharmacovigilance
· Knowledge of global pharmacovigilance regulations and processes
· Strong written and verbal communication/presentation skills
· Client-oriented attitude with focus on creating strong long-term relationships with clients and encouraging others to work toward this goal
· Ability to assure timely completion of assignments
· Skilled in problem identification and problem solving
KEY TASKS & RESPONSIBILITIES:
Point of contact for the Medical Support to the Qualified Person Responsible for Pharmacovigilance in the EU (QPPV), Deputy QPPV and General Manager for the safety activities of the company products.
To provide medical review to all risk management activities in the pharmacovigilance department.
Medical review of all the ICSR’s in the company safety database are completed under the compliance.
Prepare response to competent authority’s requirements regarding pharmacovigilance
Assist in evaluation/assessment of new products on safety concerns
Identifies, communicates and effectively manages potential safety issue
Assist in preparation of clinical & non-clinical overviews/summaries for dossiers.
Preparation of clinical & non-clinical expert statement for renewals of product.
Medical/clinical support for dossier review and clinical study report review.
Medical support in transfer of marketing authorization.
Review of the product information (SmPC & PL) and providing impact assessment
Responsible for performing activities that are in compliance with applicable Corporate and departmental Policies, Standard Operating Procedures
Send resumes to: email@example.com