Pharmacovigilance Associate, Safety Data Management

IN10 Alvotech Biosciences India PVT Ltd; Bengaluru; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Alvotech seeks a Pharmacovigilance (PV) Associate to handle Clinical Safety and post-marketing PV activities within the Global Safety Data Management team. You will work on ICSR/SAE management, regulatory submissions, literature and digital platform monitoring, and contribute to PV system lifecycle management.

The role requires a Master’s degree in pharmaceutical sciences or related fields and 2+ years in PV/Drug Safety.

Qualifications

• 2+ years in Pharmacovigilance/Drug Safety working in Safety data management functions with hands on experience in clinical trial safety and post-marketing PV activities
• Expertise working in Safety systems (Argus, ARISg); experience with Veeva Safety Vault is advantageous
• Proven track record working with global products and clinical trials
• Knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS)

Responsibilities

• Work on assigned Clinical Safety and post-marketing PV tasks (ICSR/SAE management, regulatory submissions, literature monitoring)
• Involved in Safety systems setup and lifecycle management (configuration, validation)
• Ensure compliance with international regulations and company processes
• Collaborate cross-functionally with PV, Clinical trials, Quality, Regulatory and IT teams
• Deliver trainings on pharmacovigilance processes and standards to staff and external parties
• Participate in Audits and Inspections related to Safety Data Management

Skills

Pharmacovigilance experience

Safety data management

Clinical trials

Excellent communication

Willingness to travel

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) Associate will be responsible for all assigned Clinical Safety and post-marketing PV activities. The PV Associate 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 Associate will also be involved in development of the team’s processes, and development and lifecycle management of PV systems. The PV Associate will work on assigned tasks and activities and ensuring regulatory compliance and compliance with company processes.

Scope and responsibility

• Work on assigned Clinical Safety and post-marketing PV tasks (e.g. ICSR/SAE management, Regulatory submissions, Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD, etc.)
• Involved in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.)
• Involved in maintaining and optimizing Global Pharmacovigilance processes and ensuring 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:2+ 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 working 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.

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