Placements24
1 week ago
Remote Pharmacovigilance Specialist
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Company information
- Company
- Placements24
- Location
- South Africa South Africa
- Posted
- 1 week ago
Job description
Our client, a leading global pharmaceutical company, is seeking a diligent and experienced Remote Pharmacovigilance Specialist to join their dedicated safety surveillance team. This role is crucial for monitoring the safety profile of our client's pharmaceutical products worldwide, ensuring patient safety and regulatory compliance. As a remote-first position, you will have the flexibility to work from anywhere within South Africa, contributing to critical pharmacovigilance activities from the comfort of your home office. This is an excellent opportunity to be part of a forward-thinking organization committed to ethical drug safety practices and innovation in patient care. You will play a vital role in the post-marketing surveillance of pharmaceutical products, helping to safeguard public health.
Key Responsibilities- Collect, process, and evaluate adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
- Ensure timely and accurate reporting of adverse events to regulatory authorities and internal stakeholders.
- Maintain the pharmacovigilance database, ensuring data integrity and compliance.
- Participate in signal detection and risk assessment activities.
- Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory documents.
- Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) on safety-related matters.
- Assist in the development and implementation of pharmacovigilance procedures and training materials.
- Conduct literature reviews for safety signals and emerging trends.
- Ensure compliance with global pharmacovigilance regulations and guidelines.
- Support audits and inspections related to pharmacovigilance activities.
- Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field.
- Minimum of 3-5 years of experience in pharmacovigilance or drug safety.
- Thorough knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, SAHPRA) and ICH guidelines.
- Experience with pharmacovigilance databases and safety reporting systems (e.g., Argus, ARISg).
- Strong analytical skills and attention to detail for accurate data assessment and reporting.
- Excellent written and verbal communication skills.
- Proven ability to work independently and manage workload effectively in a remote setting.
- Proficiency in Microsoft Office Suite and database management.
- Ability to collaborate effectively with geographically dispersed teams.
This fully remote role offers a competitive salary, performance bonuses, and a comprehensive benefits package including medical aid, life insurance, and a retirement fund. You will benefit from the flexibility and autonomy of working from home, with a supportive team environment. Our client invests in employee development, offering continuous learning opportunities and access to relevant training. Join a global leader in pharmaceutical safety and contribute to protecting public health from anywhere in South Africa. This role offers a significant opportunity to advance your career in pharmacovigilance.
#J-18808-LjbffrRequired skills
- remote work
- microsoft office suite
- healthcare
- audits
- risk assessment
- inspections
- database management
- regulatory compliance
- ich guidelines
- ema
- fda
- pharmacovigilance
- regulatory affairs
- south africa
- patient safety
- life sciences
- pharmaceuticals
- signal detection
- medical affairs
- clinical development
- sahpra
- drug safety
- argus
- adverse event reporting
- psur
- arisg
- safety surveillance
- pharmacovigilance databases
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