Pharmacovigilance Associate – Safety Data Management
Company: Alvotech
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full-Time
Application Deadline: March 23, 2026
Job Requisition ID: JR100089
Experience Required
Minimum 2+ years of experience in Pharmacovigilance or Drug Safety, specifically in Safety Data Management functions supporting clinical trial safety and post-marketing pharmacovigilance activities within the pharmaceutical or biotechnology industry.
Education Qualification
Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, Life Sciences, or a related scientific or medical discipline.
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines. The company’s Research and Development (R&D) division operates through the integrated Clinical and Medical Research (iCMR) department, which develops strategies aligned with biosimilar regulatory guidelines and global health authority requirements. The department supports clinical development programs and post-marketing activities while continuously optimizing operational processes.
Job Overview
The Pharmacovigilance Associate – Safety Data Management will support global pharmacovigilance operations related to clinical safety and post-marketing surveillance. The role will be part of the Global Safety Data Management team and will report to the Safety Data Management Director.
The position focuses on managing safety data from clinical trials and marketed products while ensuring accurate pharmacovigilance reporting, regulatory compliance, and adherence to company safety processes.
Key Responsibilities
Support assigned pharmacovigilance activities related to clinical safety monitoring and post-marketing surveillance programs.
Manage Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) processing activities in accordance with regulatory timelines.
Assist in regulatory safety submissions and reporting requirements for global regulatory authorities.
Conduct literature monitoring and digital platform monitoring to identify potential safety signals.
Perform pharmacovigilance reconciliation activities and support electronic reporting processes including EudraVigilance (EV) and XEVMPD.
Participate in safety system setup and lifecycle management including configuration, validation, and maintenance.
Assist in maintaining and optimizing global pharmacovigilance processes while ensuring compliance with international regulatory standards.
Collaborate with pharmacovigilance teams including Benefit-Risk Management, Clinical Trials, and Partner Compliance to ensure timely deliverables.
Work cross-functionally with internal departments such as Quality Assurance, Regulatory Affairs, Information Technology, and Clinical Product Development.
Coordinate with external pharmacovigilance service providers and business partners to ensure regulatory compliance.
Support pharmacovigilance training initiatives for internal staff and external stakeholders.
Participate in internal audits and regulatory inspections related to safety data management activities.
Required Skills and Competencies
Hands-on experience working with pharmacovigilance safety databases such as Argus Safety or ARISg.
Experience with Veeva Safety Vault is considered an advantage.
Strong knowledge of global pharmacovigilance regulations and guidelines including 21 CFR, ICH, GVP, GCP, and CIOMS standards.
Experience supporting pharmacovigilance activities for global clinical trials and marketed products.
Strong analytical, documentation, and organizational skills with high attention to detail.
Ability to manage multiple safety activities and meet regulatory deadlines.
Excellent written and verbal communication skills.
Ability to work independently while collaborating effectively within cross-functional and multicultural teams.
Preferred Qualifications
Experience working with biologic products or combination products is considered advantageous.
Previous exposure to global pharmacovigilance programs and clinical trial safety management is desirable.
Additional Requirements
Strong time management and self-organizational abilities.
Ability to maintain a result-oriented and compliant work environment.
Willingness to travel internationally when required for project collaboration, training, or regulatory inspections.
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) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
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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 :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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