Job Title:
Pharmacovigilance Manager
Job Summary:
Alvotech is hiring a Pharmacovigilance Manager to lead and manage global pharmacovigilance (PV) operations, ensuring full compliance with international safety and regulatory standards. The role requires collaboration with cross-functional teams such as Clinical Development, Patient Safety, Medical Affairs, and Regulatory Affairs to manage post-marketing safety activities and clinical programs. This position offers an exciting opportunity to shape the safety landscape of Alvotech’s innovative biosimilar portfolio.
Key Responsibilities:
Oversee all PV activities within the Pharmacovigilance department.
Develop and manage Alvotech's Global PV system, including post-marketing and clinical safety.
Collaborate with Clinical Development, Patient Safety, and other internal stakeholders to ensure PV alignment.
Engage with external partners like CROs and service providers to ensure PV compliance.
Manage post-marketing PV operations for assigned products and clinical programs.
Lead global PV functions such as ICSR/SAE processing, signal management, literature monitoring, periodic reporting, risk management, and regulatory submissions.
Ensure PV system compliance with global regulations and manage audits and inspections.
Conduct PV training for staff and external stakeholders.
Required Skills & Qualifications:
Master's degree in pharmaceutical sciences, medicine, pharmacy, or life sciences.
Minimum 5 years of PV experience in the pharmaceutical industry; biosimilar experience is a plus.
Proficiency in safety databases, MS Office, Adobe, SharePoint, DocuSign, and Veeva suite.
Deep understanding of PV regulations, GVP, ICH, CIOMS, 21CFR, GCP-R3, and related guidelines.
Excellent communication skills in English (written and spoken).
Ability to work independently, prioritize tasks, and manage time effectively.
Strong team collaboration and adaptability to multicultural work environments.
Willingness to travel internationally as needed.
Perks & Benefits:
Opportunity to work on global, impactful projects in biosimilars.
Inclusive, innovative, and diverse international work culture.
Flexible working environment with a focus on work-life balance.
Home internet and office equipment support.
Training programs and global career advancement opportunities.
Structured and transparent organizational growth path.
Company Description:
Alvotech is a global biopharmaceutical company committed to expanding access to affordable biologic medicines worldwide. The company is recognized for its innovative biosimilar development and its strong focus on safety, quality, and regulatory compliance in the pharmaceutical industry.
Work Mode:
On-site (India)
Call to Action:
Ready to take your pharmacovigilance career to the next level? Apply now and contribute to Alvotech’s mission of delivering safe and affordable biosimilars to patients across the globe.
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