Manager Pharmacovigilance, QPPV

Тalent Factor is a Talent Agency born from a dream. The dream of how, using the resource of our Talent, we can be useful in finding, developing and realizing other talents. People and businesses need a talent revolution.

We’re here to make things happen!

For our client, a large-scale manufacturing company, we are looking for:

Manager Pharmacovigilance, QPPV

Position Overview: As the Manager Pharmacovigilance, QPPV, you will play a key role in ensuring the safety and efficacy of our products throughout their lifecycle. You will be responsible for leading the pharmacovigilance team, overseeing adverse event reporting and management, and implementing pharmacovigilance processes and procedures in compliance with regulatory requirements.

Main Responsibilities:

• Lead and mentor the pharmacovigilance team, providing guidance and support in adverse event reporting and management activities.
• Oversee the timely and accurate processing of adverse event reports, including case intake, assessment, documentation, and reporting to regulatory authorities.
• Develop and implement pharmacovigilance processes and procedures in accordance with global regulations and guidelines (e.g. EMA, EAEU).
• Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other departments to ensure pharmacovigilance requirements are integrated into product development and commercialization activities.
• Conduct pharmacovigilance training for internal stakeholders and external partners to raise awareness and ensure compliance with pharmacovigilance requirements.
• Monitor and assess the safety profile of our products, identifying potential safety signals and developing risk management strategies as needed.
• Prepare and review pharmacovigilance documents, including safety reports, risk management plans, and periodic safety update reports (PSURs).
• Point of contact and control function over the specialized service providers for pharmacovigilance and drug safety services in our representative offices outside Bulgaria.
• Participate in in-licensing and out-licensing deals with contractors and partners regarding Pharmacovigilance.
• Prepare, update and review all the Pharmacovigilance-related Agreements.

Qualifications:

• Master’s degree in medicine.
• Minimum of 5 years of experience in pharmacovigilance. Experience in a managerial or leadership role will be considered an advantage.
• Strong knowledge of pharmacovigilance regulations and guidelines, including EMA, and ICH requirements.
• Experience in adverse event reporting and management, signal detection, risk management, and safety surveillance.
• Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Proven track record of managing pharmacovigilance processes and procedures in a pharmaceutical company.
• Ability to thrive in a fast-paced environment, prioritize tasks, and adapt to changing priorities.

The Company Offers:

• Opportunity to join a leading international business.
• An interesting, challenging job in a highly motivated and friendly team.
• Development and training.
• Freedom to fully bring in your individual strengths and skills.
• Excellent work conditions.

Only short-listed candidates will be contacted!

We always properly take care of all applications, and you can be sure that the personal details of every single one of you will be treated with the utmost respect, confidentiality, and full compliance with the Personal Data Protection Law.

Talent Factor holds a license from the National Employment Agency with No. 3647 dated 19.01.2024.