Pharmacovigilance Specialist – Safety Data Management
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time
Experience: Typically 3+ 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 Specialist – Safety Data Management to manage clinical safety and post-marketing pharmacovigilance activities.
The PV Specialist will be responsible for handling safety data management activities across clinical trials and post-marketing programs, while also contributing to PV system development and process optimization. The role requires independent ownership of assigned activities and strong adherence to global regulatory requirements.
Key Responsibilities
Safety Data Management
Manage Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs).
Handle regulatory submissions including EudraVigilance (EV) and XEVMPD.
Perform literature monitoring and digital safety surveillance.
Conduct safety data reconciliation across systems and sources.
Clinical & Post-Marketing PV Activities
Support pharmacovigilance activities for clinical trials and post-marketing programs.
Ensure timely processing and reporting of safety data.
Maintain compliance with global PV requirements.
Safety Systems & Lifecycle Management
Participate 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 Development & Compliance
Develop, maintain, and optimize global pharmacovigilance processes.
Ensure compliance with international regulations including Food and Drug Administration, European Medicines Agency, and ICH guidelines.
Support continuous improvement of PV workflows and systems.
Cross-Functional Collaboration
Collaborate with PV teams including Benefit-Risk Management and Clinical Trials teams.
Work with Quality, Regulatory, IT, and external partners.
Ensure timely delivery of activities and compliance.
Training, Audits & Inspections
Deliver training on pharmacovigilance processes and standards.
Support audits and regulatory inspections.
Ensure inspection readiness and compliance.
Required Skills
Pharmacovigilance Expertise
Strong experience in clinical and post-marketing pharmacovigilance.
Hands-on experience in safety data management and case processing.
Understanding of ICSR and SAE workflows.
Systems & Technical Knowledge
Experience with safety databases such as Argus and ARISg.
Familiarity with Veeva Safety Vault systems.
Knowledge of EudraVigilance and XEVMPD processes.
Regulatory & Compliance Knowledge
Knowledge of global PV regulations including ICH, GVP, GCP, and CIOMS.
Understanding of regulatory frameworks such as Food and Drug Administration and European Medicines Agency.
Experience ensuring compliance in pharmacovigilance operations.
Communication & Organization
Strong communication and interpersonal skills.
Good organizational and time management abilities.
Ability to work independently and in cross-functional teams.
Preferred Qualifications
Experience with biologics or biosimilar products.
Experience working with global clinical trials and safety systems.
Exposure to PV system implementation or enhancements.
Key Competencies
Safety data management and case processing
Clinical and post-marketing pharmacovigilance
Regulatory compliance (FDA, EMA, ICH, GVP)
PV systems and lifecycle management
Cross-functional collaboration
Audit and inspection readiness
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines.
Through 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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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
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Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
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Croatia |Zagreb :
Zagreb |Estonia :
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Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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