Job Title: Pharmacovigilance Expert
Job Description:
The Qualified Person for Pharmacovigilance will play a pivotal role in ensuring compliance with pharmacovigilance regulations and Good Vigilance Practice (GVP). This includes managing pharmacovigilance systems, quality management, standard operating procedures, contractual arrangements, database operations, compliance data, audit reports, and training of personnel.
The ideal candidate will have an overview of medicinal product safety profiles, emerging safety concerns, and risk minimisation measures. They must be aware of protocols for post-authorisation safety studies and conduct pharmacovigilance to ensure the necessary quality of data submitted to competent authorities.
Main Responsibilities:
* Develop and implement pharmacovigilance strategies to minimise risks and ensure regulatory compliance
* Manage and maintain accurate records of pharmacovigilance data, including adverse event reports and risk management plans
* Collaborate with cross-functional teams to develop and implement quality management processes
* Stay up-to-date with relevant laws and regulations governing pharmacovigilance
Requirements:
The successful candidate will have a life science degree, preferably within pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology, and a minimum of 5 years' experience in the pharmaceutical industry.
Benefits:
This is an exciting opportunity to contribute to the development and implementation of effective pharmacovigilance strategies, ensuring the highest level of patient safety and compliance with regulatory requirements.