Principal Specialist – Pharmacovigilance Quality
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time | Remote
Experience: Typically 5–8+ Years (Pharmacovigilance / Quality Assurance)
Qualification: Pharmacist or Degree in Life Sciences / Healthcare or equivalent
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Principal Specialist – Pharmacovigilance Quality to support quality oversight and advisory across pharmacovigilance systems.
The role involves acting as a quality partner to subject matter experts, ensuring integration of quality standards and compliance within pharmacovigilance activities. The position focuses on quality assurance, inspection readiness, and risk-based oversight aligned with global regulatory expectations.
This role plays a key part in supporting pharmacovigilance system transformation, quality processes, and strategic initiatives within clinical and medical research functions.
Key Responsibilities
Pharmacovigilance Quality Oversight
Act as a quality partner for pharmacovigilance (PV) activities.
Ensure integration of quality advisory and oversight within PV systems.
Support quality governance across product-level and strategic initiatives.
Inspection & Audit Management
Support PV and PADE inspection readiness activities.
Participate in coordination of regulatory inspections and audits.
Contribute to audit follow-up activities and compliance tracking.
Quality Review & Risk Management
Conduct quality evaluation of internal PV records and documentation.
Assess pharmacovigilance service providers and business partners.
Identify procedural gaps and support risk management initiatives.
Deviation & CAPA Management
Engage in complex non-compliance investigations.
Approve investigations related to PV non-compliance.
Review and approve CAPAs, effectiveness checks, and supporting evidence.
Systems & Documentation Management
Manage workflows within Veeva Vault Quality systems.
Maintain CMQ-owned documents and records in Veeva.
Ensure proper documentation and audit trails are maintained.
PV System Development & Transformation
Contribute to PV system transformation initiatives.
Support development and improvement of pharmacovigilance processes.
Align quality practices with innovation initiatives in iCMR and CMQ.
Required Skills
Pharmacovigilance & Quality Expertise
Strong experience in pharmacovigilance and quality assurance.
Experience with PV systems in biopharmaceutical environments.
Understanding of safety data, compliance, and PV operations.
Regulatory & Compliance Knowledge
Advanced knowledge of global PV regulations including Food and Drug Administration, European Medicines Agency, and ICH guidelines.
Experience with PV inspections and audit processes.
Understanding of regulatory requirements for marketed products.
Systems & Technical Knowledge
Experience with Veeva Vault Quality and Safety systems.
Familiarity with safety databases and data management processes.
Strong digital and systems proficiency.
Communication & Collaboration
Excellent written and verbal communication skills.
Ability to work with cross-functional and global teams.
Strong analytical and problem-solving abilities.
Preferred Qualifications
Experience supporting PV inspections by FDA and EU authorities.
Experience in pharmacovigilance system transformation initiatives.
Experience working in biosimilar or biopharmaceutical organizations.
Key Competencies
Pharmacovigilance quality oversight and compliance
Inspection readiness and audit management
Risk assessment and CAPA management
Regulatory compliance (FDA, EMA, ICH)
Veeva Vault Quality systems expertise
Cross-functional collaboration and communication
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 :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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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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Mexico |northeastern :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
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 :
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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Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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