Senior Pharmacovigilance Specialist – Safety Data Management
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time
Experience: Typically 5+ 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 Senior Pharmacovigilance Specialist – Safety Data Management to lead clinical safety and post-marketing pharmacovigilance activities.
The Senior PV Specialist will play a critical role in managing safety data across clinical trials and post-marketing programs, ensuring regulatory compliance and contributing to PV process development and system improvements. This role requires independent ownership of activities and strong expertise in global pharmacovigilance operations.
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 data sources.
Clinical & Post-Marketing PV Activities
Lead pharmacovigilance activities for clinical trials and post-marketing programs.
Ensure timely processing, review, and reporting of safety data.
Maintain compliance with global pharmacovigilance requirements.
Safety Systems & Lifecycle Management
Participate in setup, configuration, and validation of safety systems.
Support lifecycle management and enhancements 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.
Drive continuous improvement initiatives in PV operations.
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 and regulatory compliance of all activities.
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 trial and post-marketing pharmacovigilance.
Hands-on experience in safety data management and case processing.
In-depth 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
Strong 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 & Leadership
Strong communication and interpersonal skills.
Ability to work independently and manage multiple responsibilities.
Experience mentoring or guiding team members is an advantage.
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.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
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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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
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Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
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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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Surabaya |Japan :
Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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Prague |Chile :
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