Senior Pharmacovigilance Specialist – Safety Data Management
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time | Remote
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 manage clinical safety and post-marketing pharmacovigilance activities.
The Senior PV Specialist will play a key role in safety data management across clinical trials and post-marketing programs, including case processing, regulatory submissions, and PV system management. The role involves working independently while contributing to process development and system improvements within the Global Safety Data Management team.
This position is ideal for professionals looking to take ownership of PV activities and contribute to global safety operations and compliance.
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 submission 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 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 service providers.
Ensure timely delivery of safety-related 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 and post-marketing pharmacovigilance.
Hands-on experience in safety data management and case processing.
Understanding of ICSR and SAE management 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 responsibilities.
Experience mentoring or guiding junior team members is a plus.
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 and teamwork
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 :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
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Basel | Zurich |Serbia :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Australia | Richmond Hill | Renfrew | North York |Canada :
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 :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Almaty |Republic of Thailand :
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Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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