Pharmacovigilance associate, Safety data management

Alvotech; Bengaluru; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Alvotech is seeking a Pharmacovigilance Associate to handle clinical safety and post-marketing PV activities within a lean Global Safety Data Management team. You will contribute to ICSR/SAE management, regulatory submissions, and PV system lifecycle management.

The role requires a Master’s in pharmaceutical sciences and 2+ years in PV/Drug Safety, with knowledge of 21 CFR, ICH, GVP, and GCP guidelines, and willingness to travel internationally.

Qualifications

• Masters degree in pharmaceutical sciences or related fields.
• 2+ years in Pharmacovigilance/Drug Safety in safety data management.
• Experience with safety systems (Argus, ARISg); Veeva Safety Vault is a plus.

Responsibilities

• Handle assigned clinical safety and post-marketing PV tasks (ICSr/SAE management, regulatory submissions, literature monitoring, digital platform monitoring, reconciliations).
• Set up and lifecycle manage PV systems (configuration, validation, lifecycle).
• Maintain and optimize global PV processes ensuring regulatory and company compliance.

Skills

Pharmacovigilance

Safety data management

Communication skills

Regulatory compliance

Global trials

Education

Master's in pharmaceutical sciences

Tools

Argus

ARISg

Veeva Safety 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)Associatewillbe responsible forallassignedClinical Safetyand post-marketingPVactivities.ThePVAssociatewill 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.ThePVAssociatewillalsobe involved indevelopmentof theteam’s processes,and development andlifecycle managementofPVsystems.The PVAssociatewillworkonassignedtasks andactivitiesandensuringregulatory complianceand compliance with company processes.

Scope and responsibility

• Work on assignedClinical Safetyand post-marketingPVtasks(e.g.ICSR/SAE management,Regulatory submissions,Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD,etc.)
• InvolvedinSafety systemssetup and lifecycle management (e.g.configuration, validation, system lifecycle management, etc.)
• Involved inmaintainingandoptimizingGlobal Pharmacovigilance processes and ensuringcompliance 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: 2+years inPharmacovigilance/Drug Safetyworking in Safety data managementfunctionswith demonstrablehands onexperienceinclinical trial safetyand post-marketing PV activities
• Expertiseworking inSafety 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