Job Summary
Alvotech is seeking a Pharmacovigilance Manager for a full-time position based in India. This role offers an exciting opportunity to oversee global pharmacovigilance systems for both clinical and post-marketing activities. The ideal candidate will have over 5 years of PV experience in the pharmaceutical industry, preferably with biosimilars, and be well-versed in global PV guidelines, risk management, and safety databases. The position requires cross-functional collaboration with Clinical Development, Regulatory Affairs, and external stakeholders to maintain the highest standards of drug safety and patient care.
Key Responsibilities
Lead and manage all global pharmacovigilance (PV) activities across Alvotech’s product portfolio.
Oversee development and maintenance of the Global PV system, including post-marketing and clinical safety processes.
Ensure cross-functional collaboration with Clinical Development, Medical Affairs, Patient Safety, and Regulatory Affairs.
Manage PV-related tasks such as ICSR/SAE processing, literature surveillance, signal detection, risk management, and periodic reporting.
Ensure PV system compliance with global regulations and industry standards (21CFR, GCP-R3, GVP, ICH-GCP, CIOMS).
Conduct and support internal and external PV audits and inspections.
Deliver training to staff and external partners on PV processes and standards.
Interface with CROs and service providers to guarantee PV compliance and quality performance.
Contribute to clinical study programs through management of clinical safety activities.
Perform risk assessment and drive continuous improvement of PV systems and procedures.
Required Skills & Qualifications
Master’s Degree in Pharmaceutical Sciences, Medicine, Pharmacy, or Life Sciences.
Minimum 5 years of experience in the pharmaceutical industry with demonstrable pharmacovigilance expertise.
Experience in biosimilars is highly desirable.
Strong knowledge of global PV regulations, directives, and guidelines (21CFR, GCP-R3, GVP, ICH, CIOMS).
Proficiency in safety databases and technical software (Microsoft Office, Adobe, SharePoint, DocuSign, Veeva suite).
Excellent verbal and written English communication skills.
Proven ability to work independently and collaboratively within cross-functional teams.
High level of accountability, organizational skills, and time management.
Positive attitude with a results-oriented mindset.
Ability to adapt to multicultural environments and willingness to travel internationally as needed.
Perks & Benefits
Opportunity to work on impactful global biosimilar development programs.
Collaborative, flexible, and innovative work environment.
Clear organizational structure supporting professional growth.
Comprehensive training programs and international career advancement opportunities.
Strong focus on work-life balance.
Home internet and home office equipment support.
Exposure to a diverse and inclusive global team culture.
Company Description
Alvotech is a global leader in biosimilar development, dedicated to improving access to affordable biologic medicines. The company operates in a highly innovative and quality-driven environment, fostering collaboration and scientific excellence across its global network.
Work Mode
On-site, India (with international travel as required)
Call to Action
If you are passionate about drug safety and eager to make an impact in global pharmacovigilance, apply now to join Alvotech’s mission of enhancing patient care through affordable biologics.
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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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Frank Scottile Blvd |Missouri :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
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Basel | Zurich |Serbia :
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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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Brinny | Ringaskiddy |Carlow :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
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China | Quarry Bay |Liaoning :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
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 :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
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Montreal |Brussels :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |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 :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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Bucharest |Buenos Aires :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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