Pharmacovigilance officerAXIS ONLINE VENTURES INC.

Salary Details
PHP 75,000
Job Address
Parañaque, Metro Manila
Job Description
Qualifications:
-Degree in Pharmacy/Pharmacology or Bachelor of Science in Nursing with valid PRC License
3 yrs exp in Pharmacovigilance
Experienced in Adverse Event Reporting to FDA & DOH procedure
Knowledgeable of authorizations like Certificate of Product Registration (CPR) or Emergency Use Authorization (EUA)
Responsibilities: 
Shall maintain an effective Pharmacovigilance system of the Company
Shall act as the contact point of Food and Drug Administration (FDA) during inspection and monitoring and respond promptly for any request/inquiry from FDA;
Should have a thorough knowledge of FDA regulations, particularly on Pharmacovigilance;
Shall have a thorough knowledge of the Company’s pharmaceutical products and an overview of the safety profiles and any emerging safety concerns of the products which the Company holds authorizations (Certificate of Product Registration (CPR) or Emergency Use Authorization (EUA);
Shall maintain a company database of all adverse events involving their products and have on file all reported cases;
Shall conduct in-depth interviews with patients and health care professionals;
Shall write and review reports on adverse events of the Company’s drugs and vaccines;
Shall complete and submit periodic safety update reports on the Company’s drugs and vaccines to FDA; and
Shall submit an annual report regarding the regular, documented training/and updates conducted by the company for its PV staff
Job Requirements
Pharmacovigilance Officer
Job Type
Medical/Pharmaceutical
Working Hours
08:00 AM to 06:00 PM
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NCR, Metro Manila, Parañaque, Philippines
3 Years
Full-time
PHP 75,000
Bachelor's / College Degree
10 Vacancies