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Pharmacovigilance Manager

5+ years
₹30 – ₹40 LPA
10 June 13, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Pharmacovigilance Manager
Location: India
Job Type: Full-time
Application Deadline: June 29, 2025

Alvotech is seeking a Pharmacovigilance Manager to lead global pharmacovigilance (PV) initiatives, ensuring safety standards across clinical and post-marketing phases. In this impactful role, you will develop and manage Alvotech’s global PV system, collaborate across departments, and drive compliance with international regulatory requirements, all while contributing to the success of our biosimilar product portfolio.

This role is ideal for professionals with strong PV experience, especially those familiar with biosimilars, and looking to work in a fast-paced, cross-functional, and globally integrated environment.

Scope & Responsibilities:

  • Provide leadership across all pharmacovigilance activities within the organization.

  • Manage and develop Alvotech’s Global PV system, covering both post-marketing and clinical safety domains.

  • Collaborate with teams including Clinical Development, Medical Affairs, Patient Safety, and Regulatory Affairs to ensure unified safety strategy and operations.

  • Coordinate with external partners (CROs, vendors) to maintain quality PV operations.

  • Handle safety operations such as ICSR/SAE processing, signal detection, periodic safety reports, literature surveillance, and risk management plans.

  • Ensure compliance with global PV and clinical safety regulations, and prepare for audits and inspections.

  • Deliver internal and external training on PV procedures, regulatory standards, and documentation practices.

Job Requirements:

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

  • Minimum 5 years’ experience in pharmacovigilance, preferably within biosimilar or biologics development.

  • Solid understanding of PV regulations and global safety guidelines (e.g., ICH, GVP, GCP-R3, 21CFR).

  • Proficient in using PV databases and tools such as Veeva, Adobe, SharePoint, Microsoft Office, and DocuSign.

  • Strong communication and team coordination abilities, with fluency in written and spoken English.

  • Capable of working independently, with excellent organizational and time-management skills.

  • Ability to adapt to multicultural settings and willingness to travel internationally.

What We Offer:

  • A meaningful opportunity to make a direct impact on global healthcare.

  • The chance to work on ambitious, innovative projects with a talented international team.

  • A dynamic company culture built on inclusion, respect, and scientific excellence.

  • Flexible working conditions with home internet and office equipment support.

  • Structured training and global career advancement opportunities.

  • A balanced and supportive work environment with a clearly defined organizational framework.

Estimated Salary: ₹30 – ₹40 LPA, based on experience and qualifications.