Pharmacovigilance Manager

Overview of role:

Join Alvotech as a Pharmacovigilance Manager and become a key player in our mission to deliver safe and effective treatments to patients worldwide. In this dynamic role, you will lead and manage global pharmacovigilance activities, ensuring compliance with international safety standards and regulations. You will work cross-functionally with various departments, including Clinical Development, Patient Safety, Medical Affairs, and Regulatory Affairs, to support all safety-related activities.

Your expertise will be crucial in developing and maintaining our Global PV system, covering both post-marketing pharmacovigilance and clinical safety activities. As a Pharmacovigilance Manager, you will collaborate with internal teams and external partners to ensure the highest standards of safety and quality. This position offers an exciting opportunity to make a significant impact on patient safety and contribute to the success of Alvotech's innovative biosimilar product portfolio.

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

We encourage you to visit our Career page (link: Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.

Key Responsibilities:

• Leadership in Pharmacovigilance: Oversee and engage in all PV activities within the Pharmacovigilance department.
• Global PV System Management: Develop and manage Alvotech's Global PV system, encompassing both post-marketing and clinical safety activities.
• Cross-Functional Collaboration: Work closely with Clinical Development, Patient Safety, Medical Affairs, and other departments to support safety-related activities.
• Stakeholder Engagement: Collaborate with internal teams (e.g., Regulatory Affairs, Pharmaceutical Sciences) and external partners (e.g., CROs, service providers) to ensure PV compliance and performance.
• Safety Management: Manage post-marketing PV activities for assigned products and clinical safety activities for assigned clinical study programs.
• Comprehensive PV Activities: Oversee global pharmacovigilance tasks including ICSR/SAE processing, literature monitoring, signal management, periodic reporting, risk management, and regulatory submissions.
• Quality and Compliance: Ensure the PV system is fully compliant with global PV and clinical safety legislation and manage PV audits and inspections.
• Training and Development: Deliver training on pharmacovigilance processes and standards to staff and external parties.

Qualifications:

• Education: Master's Degree in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences).
• Experience: Minimum of 5 years in the pharmaceutical industry with demonstrable PV knowledge. Experience with biosimilars is a strong advantage.
• Technical Skills: Proficiency in safety databases, Microsoft Office tools, and technical software (Adobe, SharePoint, DocuSign, Veeva suite).
• Regulatory Knowledge: Detailed understanding of PV processes, directives, regulations, and international guidelines (21CFR, GCP-R3, GVP, ICH, CIOMS etc.).
• Communication Skills: Fluent in verbal and written English, with excellent communication and team collaboration skills.
• Independence and Accountability: Ability to work independently, manage time effectively, and prioritize tasks.
• Positive Work Environment: Maintain a positive, result-oriented work environment and foster a team spirit.
• Cultural Adaptability: Ability to work in a multicultural environment and willingness to travel internationally as required.