Pharmacovigilance Specialist, Safety data management

IN10 Alvotech Biosciences India PVT Ltd; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Alvotech is recruiting a Pharmacovigilance Specialist to lead safety data management for clinical trials and post-marketing PV activities. You will join the Global Safety Data Management team and own assigned activities to ensure regulatory compliance and timely delivery.

The role emphasizes ICSR/SAE management, literature and digital platform monitoring, and PV systems lifecycle. A Master’s degree and 3+ years PV experience are required, with international travel as needed.

Qualifications

• Master’s degree in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences).
• 3+ years in Pharmacovigilance/Drug Safety with hands-on safety data management.
• Experience with global PV regulations and post-marketing safety activities.

Responsibilities

• Manage assigned clinical safety and post-marketing PV activities (ICSR/SAE management, regulatory submissions).
• Participate in safety systems setup and lifecycle management (configuration, validation, lifecycle).
• Ensure compliance with FDA, EMA, ICH; collaborate with Quality, Regulatory and IT teams.
• Deliver PV trainings; support audits/inspections related to Safety Data Management.

Skills

Communication skills

Time management

Interpersonal skills

Education

Master’s degree in pharmaceutical sciences or related fields

Tools

Argus

ARISg

Veeva Safety Vault

Job description

About the Department/Company

Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities. iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:

Overview of Job Role

The Pharmacovigilance (PV) Specialist will be responsible and accountable for all assigned Clinical Safety and post-marketing PV activities. The Pharmacovigilance Specialist will be part of the newly developed, lean and efficient, Global Safety Data Management team, reporting to the Safety Data Management Director. The focus of this role will be on Safety data management activities for company Clinical trials as well as post-marketing programs. The PV specialist will also be involved in development of the team’s processes, PV systems development and lifecycle management. The PV specialist will work independently, own assigned activities and ensure regulatory compliance.

Scope and responsibility

• Work on assigned Clinical Safety and post-marketing PV activities (e.g. ICSR/SAE management and regulatory submissions, Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD, etc.)
• Participate in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.)
• Create, maintain and optimize Global Pharmacovigilance processes and ensure compliance with international law and regulations (e.g. FDA, EMA, ICH).
• Work cross-functionally with other PV department teams and other teams (e.g. Benefit-Risk management, Clinical trials and Partner Compliance), provide inputs and ensure on-time delivery and compliance
• Work cross-functionally with other teams and departments in the company (e.g. Quality, Regulatory, IT, CPD, etc.) and externally with PV service providers and Business partners
• Deliver trainings on pharmacovigilance processes and standards to company staff and external parties
• Involved in Audits and Inspections related to Safety Data Management activities

Job requirements

• Education:Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences
• Experience:3+ years inPharmacovigilance/Drug Safety working in Safety data management functions with demonstrable hands on experience in clinical trial safety and post-marketing PV activities
• Expertise in Safety systems (e.g.,Argus, ARISg); previous experience with Veeva Safety Vault is great advantage
• Proven track record working withglobal Products and Clinical trials
• Previous experience with biologic and combination products is an advantage
• Detailed knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.)
• Mature self-organizational, time-management and interpersonal skills
• Excellent communication skills, maintains a positive, result oriented work environment
• Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team.
• Willingness to travel internationally, as required

At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale.

If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide.

If you have any technical issues, please contact: [e-mail]