Pharmacovigilance Officer - Paranaque

Pharmacovigilance Officer - Paranaque

Cobden & Carter International
3-10 years
Not Specified

Job Description

Qualifications:
Degree in Pharmacy/Pharmacology or Bachelor of Science in Nursing with valid Professional Regulation Commission (PRC) License;
At least 3 years of working experience in Pharmacovigilance;
Experience in Vaccines
Knowledgeable of Food and Drug Administration (FDA) regulations;
Good verbal and written communication skills;
Organized and attentive to details;
Demonstrate pro-active approaches to problem-solving with strong decision-making capability;
Computer proficient and capable in Microsoft Office, Google Suite, etc.
Job Description:
We are looking for a Pharmacovigilance Officer who will be responsible for monitoring and reporting of effectiveness and any adverse effects or side effects of pharmaceutical products.
Roles and 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 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 report on the Company’s drugs and vaccines to FDA; and
Shall submit an annual report regarding the regular, documented trainings/and updates conducted by the company for its PV staff

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