Job description

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.