Pharmacovigilance Specialist – 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: JR100092
Experience Required
Minimum 3+ years of experience in Pharmacovigilance or Drug Safety, particularly in Safety Data Management functions supporting clinical trial safety and post-marketing pharmacovigilance activities in the pharmaceutical or biotechnology industry.
Education Qualification
Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, Life Sciences, or a related scientific discipline.
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company dedicated to 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 successful clinical development programs and post-marketing activities while continuously optimizing operational processes and compliance frameworks.
Job Overview
The Pharmacovigilance Specialist – Safety Data Management will support global pharmacovigilance operations related to clinical safety and post-marketing surveillance activities. This role is part of Alvotech’s Global Safety Data Management team and reports to the Safety Data Management Director.
The position focuses on safety data management for clinical trials and marketed products, ensuring accurate pharmacovigilance reporting, regulatory compliance, and continuous improvement of safety systems and pharmacovigilance processes. The specialist will work independently while managing assigned safety activities and collaborating with cross-functional teams.
Key Responsibilities
Manage assigned clinical safety and post-marketing pharmacovigilance activities including ICSR and SAE case processing and regulatory submissions.
Perform literature monitoring and digital platform monitoring to identify potential safety signals.
Conduct pharmacovigilance reconciliation activities and electronic reporting processes including EudraVigilance (EV) and XEVMPD.
Participate in safety system setup, configuration, validation, and lifecycle management activities.
Create, maintain, and optimize global pharmacovigilance processes to ensure compliance with international regulatory requirements.
Collaborate with pharmacovigilance teams including Benefit-Risk Management, Clinical Trials, and Partner Compliance to ensure timely safety 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 support global safety operations.
Deliver pharmacovigilance training programs and guidance to internal teams and external stakeholders.
Participate in pharmacovigilance audits and regulatory inspections related to safety data management activities.
Required Skills and Competencies
Hands-on experience with pharmacovigilance safety databases such as Argus Safety or ARISg.
Experience with Veeva Safety Vault is considered an advantage.
Strong understanding 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 pharmaceutical products.
Strong analytical, organizational, and documentation skills with high attention to detail.
Ability to manage multiple pharmacovigilance tasks while meeting regulatory deadlines.
Excellent written and verbal communication skills.
Ability to work independently while collaborating effectively with cross-functional and multicultural teams.
Preferred Qualifications
Experience working with biologic products or combination products is considered advantageous.
Previous experience supporting global clinical trials and pharmacovigilance programs is desirable.
Additional Requirements
Strong time management and self-organizational skills.
Ability to maintain a compliant and result-oriented 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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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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 :
Atlanta | Augusta | Rome |Maine :
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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 :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Dún Laoghaire |Galway :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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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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Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
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Ciudad de México | New Mexico |Dubai :
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Rabigh | Jeddah | Khulais | Riyadh | King Abdullah Economic City | Najran |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
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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