Job Summary:
Alvotech is hiring a skilled Pharmacovigilance Manager for its Stockholm, Sweden location. This critical role offers the opportunity to lead global pharmacovigilance operations, ensuring the highest compliance with international drug safety standards. You will collaborate with multiple departments—including Clinical Development, Medical Affairs, and Regulatory Affairs—to manage both post-marketing and clinical safety activities. Ideal candidates will have a solid background in PV processes and international guidelines (ICH-GCP, GVP) and a passion for biosimilar product development.
Key Responsibilities:
Lead and manage global pharmacovigilance (PV) activities in line with international regulations.
Develop and oversee Alvotech’s Global PV system for both clinical and post-marketing programs.
Ensure cross-functional collaboration with Clinical Development, Medical Affairs, Regulatory Affairs, and Patient Safety teams.
Manage stakeholder engagement with internal teams and external partners (e.g., CROs, service providers).
Oversee PV operations such as ICSR/SAE processing, signal management, periodic safety reporting, and risk management.
Ensure full compliance with GVP, ICH-GCP, CIOMS, and global safety regulations.
Conduct PV audits and inspections, ensuring corrective actions are implemented.
Deliver PV-related training sessions for internal staff and external stakeholders.
Drive continuous improvement in PV quality systems and processes.
Required Skills & Qualifications:
Master’s degree in Pharmaceutical Sciences, Life Sciences, Medicine, or Pharmacy.
Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry.
Expertise in PV guidelines, including ICH-GCP, GVP, 21CFR, CIOMS.
Proficiency in safety databases and tools: Adobe, SharePoint, DocuSign, Veeva Suite, MS Office.
Strong verbal and written English communication skills.
Ability to manage multiple projects independently.
Positive, proactive attitude with strong team spirit.
Willingness to travel internationally.
Biosimilar experience preferred.
Perks & Benefits:
Opportunity to work on groundbreaking biosimilar products.
Dynamic, diverse, and collaborative international work culture.
Clearly defined organizational structure with career advancement support.
Positive and flexible work environment fostering innovation.
Personal growth and global training programs.
Strong emphasis on work-life balance.
Home office equipment and internet support provided.
Company Description:
Alvotech is a global leader in the development and manufacturing of high-quality biosimilars, dedicated to improving global access to affordable biologic treatments. Known for innovation, compliance, and a strong scientific foundation, Alvotech fosters diversity and collaboration across its international teams.
Work Mode:
On-site – Stockholm, Sweden
(International travel required as per project needs)
Call to Action:
Ready to shape the future of global pharmacovigilance? Apply now to join Alvotech’s dynamic team and play a key role in advancing drug safety and biosimilar development.
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