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Pharmacovigilance Manager

5+ years
Not Disclosed
10 June 24, 2025
Job Description
Job Type: Full Time Education: Master’s degree Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Summary:

Alvotech is seeking a skilled Pharmacovigilance Manager for its India operations. In this pivotal role, you will lead global pharmacovigilance (PV) activities ensuring compliance with international safety standards. The position involves overseeing post-marketing and clinical safety processes, collaborating with cross-functional teams, and ensuring quality PV systems that support Alvotech’s innovative biosimilar portfolio. Ideal for professionals with a passion for patient safety and a strong background in PV systems management, this role offers an exciting career opportunity with a global pharmaceutical leader.


Key Responsibilities:

  • Lead and manage all pharmacovigilance activities within the PV department.

  • Develop and oversee Alvotech's global PV system covering clinical and post-marketing safety.

  • Collaborate with departments including Clinical Development, Medical Affairs, Regulatory Affairs, and Patient Safety.

  • Manage PV deliverables such as ICSR/SAE processing, signal detection, periodic safety reports, and risk management plans.

  • Ensure system compliance with GVP, ICH-GCP, CIOMS, 21CFR, and global regulatory guidelines.

  • Oversee PV audits, inspections, and corrective action implementation.

  • Coordinate with external stakeholders including CROs and service providers.

  • Train internal teams and external partners on PV processes and global standards.

  • Maintain quality and performance metrics in all PV operations.


Required Skills & Qualifications:

  • Master's degree in pharmaceutical sciences, life sciences, medicine, or pharmacy.

  • Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry.

  • Strong knowledge of PV regulations, ICH-GCP, GVP, 21CFR, CIOMS, and safety legislation.

  • Hands-on experience with safety databases and technical tools like Adobe, SharePoint, DocuSign, Veeva Suite, MS Office.

  • Excellent verbal and written communication in English.

  • Strong organizational and time-management skills.

  • Ability to work independently and manage multiple projects.

  • Willingness to work in a multicultural environment and travel internationally as needed.

  • Experience with biosimilars is an added advantage.


Perks & Benefits:

  • Opportunity to contribute to life-saving biosimilar products.

  • Inclusive, collaborative, and international work culture.

  • Clear organizational structure with growth and advancement opportunities.

  • Flexible and innovative work environment.

  • Home internet and home office equipment provided.

  • Global training programs and career development support.

  • Good work-life balance initiatives.


Company Description:

Alvotech is a global biopharmaceutical leader focused on developing and manufacturing affordable, high-quality biosimilars. Committed to enhancing global access to biologic treatments, Alvotech fosters innovation, inclusivity, and scientific excellence across its worldwide operations.


Work Mode:

On-site – India (International travel may be required)


Call to Action:

Are you ready to make a real impact in global pharmacovigilance? Apply now to join Alvotech’s growing team and help advance safer, affordable biologic medicines worldwide.