Job Summary:
Alvotech is seeking a skilled Pharmacovigilance Manager for its India operations. In this pivotal role, you will lead global pharmacovigilance (PV) activities ensuring compliance with international safety standards. The position involves overseeing post-marketing and clinical safety processes, collaborating with cross-functional teams, and ensuring quality PV systems that support Alvotech’s innovative biosimilar portfolio. Ideal for professionals with a passion for patient safety and a strong background in PV systems management, this role offers an exciting career opportunity with a global pharmaceutical leader.
Key Responsibilities:
Lead and manage all pharmacovigilance activities within the PV department.
Develop and oversee Alvotech's global PV system covering clinical and post-marketing safety.
Collaborate with departments including Clinical Development, Medical Affairs, Regulatory Affairs, and Patient Safety.
Manage PV deliverables such as ICSR/SAE processing, signal detection, periodic safety reports, and risk management plans.
Ensure system compliance with GVP, ICH-GCP, CIOMS, 21CFR, and global regulatory guidelines.
Oversee PV audits, inspections, and corrective action implementation.
Coordinate with external stakeholders including CROs and service providers.
Train internal teams and external partners on PV processes and global standards.
Maintain quality and performance metrics in all PV operations.
Required Skills & Qualifications:
Master's degree in pharmaceutical sciences, life sciences, medicine, or pharmacy.
Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry.
Strong knowledge of PV regulations, ICH-GCP, GVP, 21CFR, CIOMS, and safety legislation.
Hands-on experience with safety databases and technical tools like Adobe, SharePoint, DocuSign, Veeva Suite, MS Office.
Excellent verbal and written communication in English.
Strong organizational and time-management skills.
Ability to work independently and manage multiple projects.
Willingness to work in a multicultural environment and travel internationally as needed.
Experience with biosimilars is an added advantage.
Perks & Benefits:
Opportunity to contribute to life-saving biosimilar products.
Inclusive, collaborative, and international work culture.
Clear organizational structure with growth and advancement opportunities.
Flexible and innovative work environment.
Home internet and home office equipment provided.
Global training programs and career development support.
Good work-life balance initiatives.
Company Description:
Alvotech is a global biopharmaceutical leader focused on developing and manufacturing affordable, high-quality biosimilars. Committed to enhancing global access to biologic treatments, Alvotech fosters innovation, inclusivity, and scientific excellence across its worldwide operations.
Work Mode:
On-site – India (International travel may be required)
Call to Action:
Are you ready to make a real impact in global pharmacovigilance? Apply now to join Alvotech’s growing team and help advance safer, affordable biologic medicines worldwide.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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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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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
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Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
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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 :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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