Open roleExternal
Pharmacovigilance Specialist
- belfast, northern ireland, BT1 1AA, United Kingdom
- Permanent·Remote
- Full time
- £60,000 - £60,000 Per Annum
Job Description
About the Role
Our client is seeking a diligent and detail-oriented Pharmacovigilance Specialist to join their global safety team. This essential role involves the critical monitoring and assessment of drug safety profiles to ensure patient well-being and regulatory compliance. Working entirely remotely, you will play a key part in the collection, evaluation, and reporting of adverse event data, contributing to the safety oversight of marketed products and clinical trial investigational drugs. This is an ideal position for a professional with a strong understanding of pharmacovigilance principles who thrives in an autonomous work environment, contributing to the safety and integrity of pharmaceutical products worldwide.
Key Responsibilities
- Process, evaluate, and report adverse event data from various sources in compliance with regulatory timelines.
- Perform literature searches for potential safety signals and emerging safety concerns.
- Contribute to the preparation of safety documents, including periodic safety update reports (PSURs) and risk management plans (RMPs).
- Liaise with internal departments and external stakeholders on safety-related matters.
- Ensure adherence to global pharmacovigilance regulations and company SOPs.
- Assist in the maintenance of safety databases and ensure data quality.
Requirements
- Degree in a health science, pharmacy, nursing, or related field.
- Proven experience in pharmacovigilance, drug safety, or a related regulatory affairs role.
- Solid understanding of global pharmacovigilance regulations (e.g., FDA, EMA).
- Proficiency in safety database software and adverse event reporting systems.
- Excellent analytical, organizational, and written communication skills.
- Ability to work independently, manage time effectively, and meet strict deadlines in a remote setting.
Benefits
- Competitive salary and potential for annual bonuses.
- Comprehensive healthcare coverage.
- Generous annual leave and paid holidays.
- Support for professional development and training in pharmacovigilance.
- A flexible and supportive remote work environment that prioritizes work-life balance.