We Are Hiring Now!
SUBMIT YOUR APPLICATION TODAY!
QUALIFICATION:
⚫ 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 relationships
⚫ Client-oriented attitude with focus on creating strong long-term
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
Please submit your cv:
sureshn@symbiance.com dhavals@symbiance.com
Location: Bangalore/Chennai Note:- Work from office*
www.symbiance.com
Symbiance
