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Pharmacovigilance Officer Jobs
Company | Docquity |
Address | Area DKI Jakarta, Indonesia |
Employment type | FULL_TIME |
Salary | |
Expires | 2023-08-02 |
Posted at | 10 months ago |
About Docquity
Docquity is Southeast Asia’s largest professional community of healthcare professionals. Our single-minded purpose is to build a trusted digital healthcare platform to elevate patient outcomes and, ultimately, build healthier lives.
Docquity connects healthcare professionals to help them be more collaborative, productive, and impactful and partners with companies to reach, educate and gain insights. Docquity has more than 350,000 healthcare professionals and has offices in India, Indonesia, the Philippines, Malaysia, Singapore, Thailand, Vietnam, and Taiwan.
About Role
The Pharmacovigilance Officer would be responsible for maintaining an effective Pharmacovigilance system of the company. Maintaining and updating a database of all adverse events would also be a crucial deliverable for this position
Job Title: Pharmacovigilance Officer
Work Experience: 2 – 3 years
Location: Jakarta
Academic Qualification: Graduate of a Medical degree (Bachelor’s) from a reputable university (ie. Medicine, Nursing, Pharmacy).
Expectations from you
- Maintain an effective Pharmacovigilance system of the Company in the assigned countries which includes but not limited to:
- Individual Case Safety Reports (ICSR) Management (e.g., monitoring of data received by the Company to ensure ICSRS are processed timely and sent to Clients, reconciliation, and follow-up of ICSR, submission to Health Authorities, as required and archiving).
- Monitor & be updated on Health Authority regulations related to Pharmacovigilance and Data Protection.
- Creates and maintains a Business Contingency Plan (BCP) for PV.
- Ensures full implementation of internal PV-related SOPs, PV Agreements, and other Client-related PV requirements.
- Provides PV-related training to internal employees and as required, subcontractor employees.
- Manages PV-related SOP/regulation deviation and its related CAPA (Corrective and Preventive Action Plan), including Write and review reports on adverse events.
- Ensures internal Quality Management implementation and Audit-preparedness for Client’s PV Audits.
- Submits other Safety-related documents to Health Authorities (e.g., Periodic Safety Update Reports) as required.
- Maintain a company database of all adverse events.
- Liaises with internal and external stakeholders.
Skills required
- Self-motivated
- Team player
- Leadership
- Critical thinking and Problem solving
- Experience in project management to be able to manage Pharmacovigilance responsibilities in countries of responsibility.
- Ability to work in a fast-paced environment.
- Goal-oriented
- Analytical
- Experience in the monitoring and implementation of local regulation linked to the job role (ie. Pharmacovigilance and Data Protection).
- Time management
- Ability to function in a cross-functional environment.
Culture at Docquity
While we have been growing fast, we are still small enough that everyone makes a pivotal difference. We care less about hours worked and more about the outcome — and the impact you make. We have worked hard to create an autonomous working culture emphasizing work/life balance and a fun working environment. We follow the hybrid work culture.
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