Pharmacovigilance Specialist – Safety Data Management
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time | Remote
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 support clinical safety and post-marketing pharmacovigilance activities.
The Pharmacovigilance Specialist will be responsible for safety data management across clinical trials and post-marketing programs, including case processing, regulatory submissions, and system management. The role involves working within the Global Safety Data Management team and ensuring compliance with global pharmacovigilance standards.
This position plays a key role in maintaining safety data integrity, supporting PV system development, and ensuring timely and compliant safety reporting.
Key Responsibilities
Safety Data Management
Manage Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs).
Handle regulatory submissions including EudraVigilance (EV) and XEVMPD activities.
Perform literature monitoring and digital platform 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 as a subject matter expert.
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 PV service providers.
Ensure timely delivery of safety-related activities.
Training, Audits & Inspections
Deliver training on pharmacovigilance processes and standards.
Support audits and regulatory inspections related to safety data management.
Ensure inspection readiness and compliance.
Required Skills
Pharmacovigilance Expertise
Strong experience in clinical trial and post-marketing pharmacovigilance.
Hands-on experience in safety data management and case processing.
Understanding of ICSR management and safety reporting 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 databases.
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 and communication
Audit and inspection readiness
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively 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 and biosimilar guidelines, enabling successful clinical trials and post-marketing activities worldwide.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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China | Quarry Bay |Liaoning :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
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Niš |Bohemia :
Prague |Chile :
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