About the Role
Our client is seeking a vigilant and experienced Remote Pharmacovigilance Specialist to join their dedicated safety surveillance team. In this fully remote role, you will play a crucial part in monitoring the safety of pharmaceutical products post-marketing, ensuring patient safety by collecting, assessing, and reporting adverse events. You will collaborate with global regulatory bodies and internal teams to maintain the highest standards of drug safety. This position is ideal for a detail-oriented professional with a strong understanding of pharmacovigilance principles and a commitment to patient well-being, working from any approved location.
Key Responsibilities
- Collect, process, and assess individual case safety reports (ICSRs) from various sources (e.g., healthcare professionals, patients, literature).
- Ensure timely and accurate submission of safety reports to regulatory authorities, including SAHPRA, in compliance with applicable regulations.
- Conduct literature searches for potential safety signals and contribute to signal detection activities.
- Prepare aggregate safety reports (e.g., Periodic Safety Update Reports - PSURs) as required.
- Collaborate with internal departments (e.g., Clinical Operations, Regulatory Affairs, Medical Information) to ensure comprehensive safety data management.
- Contribute to the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs) and training materials.
Requirements
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
- Minimum of 3 years of experience in pharmacovigilance or drug safety, preferably within the pharmaceutical industry.
- Thorough knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH E2A, E2B, E2F).
- Experience with pharmacovigilance databases and safety reporting systems.
- Excellent analytical skills, strong attention to detail, and the ability to work independently.
- Proficiency in English communication, both written and verbal, with the ability to clearly articulate safety information in a remote work environment.
Benefits
- Competitive salary and performance-related bonuses.
- Fully remote work flexibility, allowing for a better work-life balance.
- Comprehensive health, dental, and vision insurance plans.
- Opportunities for professional development and specialized training in pharmacovigilance.
- A vital role in safeguarding public health by ensuring drug safety.
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Remote Pharmacovigilance Specialist in Southampton employer: Placements24
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