Pharmacovigilance Specialist, Safety data management

Alvotech; Bengaluru; Hybrid; INR 1,200,000 - 2,400,000; Full time

Job summary

Alvotech is seeking a Pharmacovigilance Specialist to lead safety data management for clinical trials and post-marketing programs. You will work within the Global Safety Data Management team, reporting to the Director, PV.

Responsibilities include ICSR/SAE handling, literature monitoring, and PV system lifecycle management. The role requires a Master’s Degree in pharmaceutical sciences and at least 3 years of PV experience, with familiarity in Argus/ARISg and Veeva Safety Vault.

Qualifications

• Master’s Degree required in pharmaceutical sciences or related field.
• Minimum 3+ years of pharmacovigilance/safety data management experience.
• Experience with global PV processes and ICSR/SAE management.

Responsibilities

• Manage assigned Clinical Safety and post-marketing PV activities (ICSR/SAE management, regulatory submissions).
• Monitor literature and digital platforms for PI safety signals and data integrity.
• Contribute to PV system configuration, validation, and lifecycle management.
• Deliver PV process trainings to staff and external partners.
• Support audits and inspections related to Safety Data Management.

Skills

Pharmacovigilance

Safety data management

Regulatory compliance

Team collaboration

Attention to detail

Communication skills

Education

Master’s Degree in pharmaceutical sciences

Tools

Argus

ARISg

Veeva Safety Vault

Job description

## Pharmacovigilance Specialist, Safety data managementApply: Partially remote: Bangalore Office: India Home Office: Full time: Posted 2 Days Ago: End Date: September 29, 2026 (4 days left to apply): JR100100**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 in Pharmacovigilance/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 with global 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