Pharmacovigilance Specialist
- manchester, greater manchester, M1 1AE, United Kingdom
- Permanent·Remote
- Full time
- £58,000 - £58,000 Per Annum
Job Description
About the Role
Our client is looking for a meticulous and experienced Pharmacovigilance Specialist to join their dedicated safety and pharmacovigilance team based in or near Manchester . This vital role involves the ongoing monitoring of the safety profiles of pharmaceutical products, ensuring that all adverse event data is collected, assessed, and reported in compliance with global regulatory standards. You will work collaboratively with internal departments and external stakeholders to maintain the highest level of patient safety and product integrity, contributing significantly to the responsible management of their drug portfolio. This is an excellent chance to advance your career in a critical area of pharmaceutical operations with a company committed to safety and excellence.
Key Responsibilities
- Collect, assess, and document adverse event reports from various sources, including healthcare professionals, patients, and clinical trials.
- Perform medical coding of adverse events using standardized dictionaries (e.g., MedDRA) and ensure accuracy of case processing.
- Contribute to the preparation and submission of periodic safety update reports (PSURs) and other regulatory safety documents.
- Participate in signal detection activities, assisting in the identification and evaluation of potential safety signals for marketed products.
- Ensure compliance with global pharmacovigilance regulations and company standard operating procedures (SOPs).
- Liaise with external partners, investigators, and regulatory authorities on safety-related matters.
Requirements
- Bachelor's or Master's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
- Minimum of 3 years of direct experience in pharmacovigilance or drug safety.
- Solid understanding of global pharmacovigilance regulations (e.g., FDA, EMA) and reporting requirements.
- Proficiency with pharmacovigilance databases and adverse event reporting systems.
- Excellent analytical skills, attention to detail, and strong written and verbal communication abilities.
Benefits
- Competitive annual salary and potential for annual bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and company holidays.
- Opportunities for ongoing professional development and training in Manchester .
- Remote working flexibility to support a healthy work-life balance.