Pharmacovigilance Specialist, Safety data management

Alvotech; Bengaluru; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Alvotech is seeking a Pharmacovigilance Specialist to join the Global Safety Data Management team. You will handle clinical safety activities and post-marketing PV tasks, ensuring regulatory compliance and effective PV processes across trials and programs.

The role requires 3+ years in Pharmacovigilance, strong experience with PV systems, and willingness to travel internationally. You will contribute to process development, training, and audits in a fast-paced biosimilars environment.

Qualifications

• Master’s degree in pharmaceutical sciences or related field (medicine, pharmacy, life sciences).
• 3+ years in Pharmacovigilance/Drug Safety with hands-on experience in clinical safety and post-marketing PV activities.
• Expertise in PV systems (e.g., Argus, ARISg); Veeva Safety Vault is a plus.
• Proven track record working with global products and clinical trials.
• Experience with biologic and combination products is advantageous.
• Knowledge of PV processes, directives, regulations, and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS).
• Strong self-organization, time management, and interpersonal skills.
• Excellent communication and ability to work independently in a multicultural team.
• Willingness to travel internationally as required.

Responsibilities

• Work on assigned Clinical Safety and post-marketing PV activities (ICSR/SAE management, regulatory submissions, literature monitoring, digital platform monitoring, reconciliations, EV/XEVMPD).
• Participate in safety systems setup and lifecycle management (configuration, validation, system lifecycle management).
• Create, maintain and optimize Global Pharmacovigilance processes ensuring compliance with international laws and regulations (FDA, EMA, ICH).
• Collaborate cross-functionally with PV and other teams, ensure on-time delivery and compliance.
• Train staff and external parties on PV processes and standards.
• Participate in audits and inspections related to Safety Data Management activities.

Skills

Pharmacovigilance

ICSR handling

Regulatory compliance

Safety data management

Communication

Education

Master's degree in Pharmaceutical Sciences

Tools

Argus

ARISg

Veeva Vault

Job description

About the Department/Company

Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively ondevelopmentand 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.

iCMRis launching an ambitious and exciting project aimed at modernizing andoptimizingthe departmental operating model. As part of this project, we are recruiting for the following position:

Overview ofJobRole

ThePharmacovigilance(PV)Specialistwill be responsibleand accountableforallassignedClinical Safetyand post-marketingPVactivities.The PharmacovigilanceSpecialistwill be part of the newlydeveloped,leanand efficient,Global Safety Data Management team,reporting to theSafety Data ManagementDirector.The focusof this rolewill be onSafety data management activities forcompanyClinical trialsas well aspost-marketing programs.The PVspecialist willalsobe involved indevelopmentof theteam’s processes,PVsystemsdevelopmentand lifecycle management.The PVspecialistwillwork independently,own assignedactivitiesand ensure regulatory compliance.

Scope and responsibility

• Work on assignedClinical Safetyand post-marketingPVactivities(e.g.ICSR/SAE management and regulatory submissions,Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD,etc.)
• ParticipateinSafety systemssetup and lifecycle management (e.g.configuration, validation, system lifecycle management, etc.)
• Create,maintainandoptimizeGlobal Pharmacovigilance processes and ensure compliance withinternational law and regulations (e.g.FDA, EMA, ICH).
• Work cross-functionally with other PV department teams andother teams(e.g.Benefit-Risk management, Clinicaltrialsand Partner Compliance),provideinputsandensureon-timedeliveryand 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 toSafety Data Managementactivities

Job requirements

• Education: Master’s Degree inpharmaceutical sciences or related fields – medicine, pharmacy, life sciences
• Experience: 3+ years inPharmacovigilance/Drug Safetyworking in Safety data managementfunctionswith demonstrablehands onexperienceinclinical trial safetyand post-marketing PV activities
• ExpertiseinSafety systems (e.g.,Argus,ARISg);previousexperience with Veeva Safety Vault is great advantage
• Proventrack recordworkingwithglobal ProductsandClinical trials
• Previousexperience with biologic and combination products is an advantage
• Detailed knowledge of PV processes, directives,regulationsand international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.)
• Mature self-organizational, time-management and interpersonal skills
• Excellent communication skills,maintainsa positive, result oriented work environment
• Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team.
• Willingness to travel internationally, asrequired