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.
China
