Pharmacovigilance Associate – Safety Data Management
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time
Experience: Typically 2+ Years (Pharmacovigilance / Drug Safety / Safety Data Management)
Qualification: Master’s Degree in Pharmacy / Life Sciences / Medicine or related field
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Pharmacovigilance Associate – Safety Data Management to support clinical safety and post-marketing pharmacovigilance activities.
The PV Associate will be responsible for executing safety data management tasks across clinical trials and post-marketing programs, ensuring regulatory compliance and adherence to company processes. The role involves working within the Global Safety Data Management team and contributing to PV system support and process improvement.
Key Responsibilities
Safety Data Management
Process Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs).
Support regulatory submissions including EudraVigilance (EV) and XEVMPD.
Perform literature monitoring and digital safety surveillance.
Assist in safety data reconciliation activities.
Clinical & Post-Marketing PV Activities
Support pharmacovigilance activities for clinical trials and post-marketing programs.
Ensure timely execution of assigned safety tasks.
Maintain compliance with pharmacovigilance requirements.
Safety Systems & Lifecycle Support
Assist in setup, configuration, and validation of safety systems.
Support lifecycle management of PV systems.
Work with systems such as Argus, ARISg, and Veeva Safety Vault.
Process Support & Compliance
Support maintenance and optimization of global pharmacovigilance processes.
Ensure compliance with international regulations including Food and Drug Administration, European Medicines Agency, and ICH guidelines.
Follow company SOPs and regulatory standards.
Cross-Functional Collaboration
Collaborate with PV teams including Benefit-Risk Management and Clinical Trials.
Work with Quality, Regulatory, IT, and external partners.
Provide inputs to ensure timely delivery of activities.
Training, Audits & Inspections
Participate in pharmacovigilance training activities.
Support audits and regulatory inspections.
Ensure compliance with audit and inspection requirements.
Required Skills
Pharmacovigilance Knowledge
Basic experience in clinical and post-marketing pharmacovigilance.
Understanding of safety data management and case processing.
Familiarity with ICSR and SAE workflows.
Systems & Technical Knowledge
Experience with safety databases such as Argus and ARISg.
Exposure to Veeva Safety Vault is an advantage.
Basic understanding of safety reporting systems.
Regulatory & Compliance Knowledge
Knowledge of PV regulations including ICH, GVP, GCP, and CIOMS.
Awareness of regulatory frameworks such as Food and Drug Administration and European Medicines Agency.
Understanding of compliance requirements in pharmacovigilance.
Communication & Organization
Good communication and interpersonal skills.
Strong organizational and time management abilities.
Ability to work in a team-oriented and multicultural environment.
Preferred Qualifications
Experience with biologics or biosimilar products.
Exposure to global clinical trials and PV systems.
Willingness to learn and grow within pharmacovigilance domain.
Key Competencies
Safety data management and case processing
Clinical and post-marketing pharmacovigilance
Regulatory compliance (FDA, EMA, ICH, GVP)
PV systems and workflow understanding
Cross-functional collaboration
Audit and inspection support
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines.
Within its Integrated Clinical and Medical Research (iCMR) function, the organization supports clinical strategies aligned with global regulatory requirements, enabling successful clinical development and post-marketing activities worldwide.
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Siliguri |Illinois :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
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Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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