Senior Pharmacovigilance Specialist
3 days ago
About the Role
We are seeking a highly skilled Senior Pharmacovigilance Specialist to join our team at Randstad PTE LIMITED. As a key member of our Pharmacovigilance team, you will play a vital role in ensuring the safety and efficacy of our products.
Job Description
The successful candidate will be responsible for assisting with the execution of local Pharmacovigilance processes and activities, including projects with oversight by their manager or a designated colleague. This will involve:
- Collaborating with internal functional areas and external parties to execute PV activities as assigned;
- Assisting with day-to-day adverse event case management, including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations;
- Supporting Individual Case Safety Report (ICSR) Health Authority submissions in accordance with company procedures and health authority requirements, when requested;
- Assisting with aggregate safety report submissions to Health Authorities in accordance with company procedures and health authority requirements, when requested;
- Filing, storing, and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements;
- Participating in compliance activities and assisting in coordinating the preparation of necessary corrective actions locally for late reports;
- Supporting local PV audits and inspections when requested;
- Supporting PV self-inspections as required by PV Legislations (where applicable);
- Reporting adverse experiences or events (AE) or product quality complaints (PQC) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety;
- Completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity;
- Maintaining up-to-date knowledge of relevant PV regulations and guidelines;
- Performing other activities as requested by their Manager.
Requirements
To be successful in this role, you will need:
- A degree in Health, Life Science, or Medical Science, or equivalent;
- At least 1 year of Pharmacovigilance experience in the pharmaceutical industry;
- Experience in Medical Affairs/Regulatory/Clinical research related to drugs;
- Knowledge of AE reporting requirements and relevant PV regulations;
- Excellent communication and organizational skills.
About Us
Randstad PTE LIMITED is a leading global biopharmaceutical company committed to providing patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. We have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our estimated salary range for this position is approximately $80,000 - $120,000 per annum.
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