Pharmacovigilance Expert - FTC 6-12M

Luminary Group is currently seeking a skilled and experienced Pharmacovigilance Expert to join our team on a fixed-term contract basis for 6-12 months. As a Pharmacovigilance Expert, you will be responsible for overseeing and managing the pharmacovigilance activities for our client's pharmaceutical products.

Responsibilities:

• Develop and maintain pharmacovigilance system master files and standard operating procedures.
• Manage the collection, processing, and evaluation of adverse event reports.
• Lead the review and preparation of periodic safety reports.
• Conduct signal detection and analysis to identify potential safety concerns.
• Work closely with cross-functional teams to ensure compliance with pharmacovigilance regulations and guidelines.
• Provide guidance and training to team members on pharmacovigilance processes.
• Collaborate with regulatory authorities during inspections and audits.
• Stay up-to-date with the latest pharmacovigilance regulations and best practices.
• Contribute to process improvement initiatives and implementation of new pharmacovigilance systems.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or equivalent.
• Minimum of 5 years of experience in pharmacovigilance, with significant experience in managing pharmacovigilance activities for pharmaceutical products.
• Strong knowledge of pharmacovigilance regulations and guidelines.
• Experience in preparing and reviewing periodic safety reports.
• Excellent understanding of signal detection and analysis methodologies.
• Proficiency in using pharmacovigilance databases and safety reporting systems.
• Ability to lead and manage a team and provide guidance to junior members.
• Excellent attention to detail and strong analytical skills.
• Excellent communication and interpersonal skills to effectively work with cross-functional teams and regulatory authorities.
• Experience in inspections and audits by regulatory authorities is desirable.
• Knowledge of European pharmacovigilance regulations (e.g., EudraVigilance) is preferred.
• Strong project management skills and ability to handle multiple priorities.