Offer summary

Qualifications:

Advanced degree (Master’s or PhD) in Pharmacy, Life Sciences, or a related field., Minimum of 8 years of experience in pharmacovigilance, with at least 3 years in a leadership role., Strong knowledge of pharmacovigilance regulations and guidance in Europe., Excellent communication and interpersonal skills..

Key responsabilities:

Develop and implement the pharmacovigilance strategy for the region in accordance with regulatory requirements.

Lead and manage the pharmacovigilance team, ensuring high performance and professional development.

Oversee the processing and evaluation of safety reports and adverse events for all products.

Serve as the primary point of contact for regulatory authorities during inspections and audits.

Job description

Luminary Group is in search of an experienced and strategic Pharmacovigilance Director to join our client in Europe. In this leadership role, you will oversee the pharmacovigilance functions and ensure compliance with regulatory standards, while leading initiatives to enhance product safety and maintain high-quality standards.

Responsibilities:

Develop and implement the pharmacovigilance strategy for the region in accordance with regulatory requirements and industry standards.
Lead and manage the pharmacovigilance team, ensuring high performance and professional development.
Oversee the processing and evaluation of safety reports and adverse events for all products.
Conduct signal detection, risk assessments, and safety evaluations to identify potential safety issues.
Collaborate with cross-functional teams to ensure timely and accurate reporting of safety information to regulatory authorities.
Serve as the primary point of contact for regulatory authorities during inspections and audits.
Ensure compliance with pharmacovigilance regulations and internal policies, and facilitate continuous improvement initiatives.
Stay updated with the latest regulatory changes and best practices in pharmacovigilance.

Requirements

Advanced degree (Master’s or PhD) in Pharmacy, Life Sciences, or a related field.
Minimum of 8 years of experience in pharmacovigilance, with at least 3 years in a leadership role.
Strong knowledge of pharmacovigilance regulations and guidance in Europe.
Proven experience in managing teams and leading cross-functional projects.
Expertise in signal detection, risk management, and safety reporting processes.
Excellent communication and interpersonal skills, capable of building relationships with internal and external stakeholders.
Strong analytical and critical thinking skills.
Ability to work independently and make strategic decisions.
Proficiency in using pharmacovigilance databases and safety reporting systems.
Willingness to travel as needed for meetings and inspections.

Required profile