Pharmacovigilance Manager – Benefit Risk Management
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time | Remote
Experience: Typically 7+ Years (Pharmacovigilance / Drug Safety / Benefit-Risk Management)
Qualification: Master’s Degree in Pharmacy / Life Sciences / Medicine or related field
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Pharmacovigilance Manager – Benefit Risk Management to lead clinical safety and post-marketing PV activities.
The Pharmacovigilance Manager will be responsible for signal detection, benefit-risk evaluation, risk management, and periodic safety reporting across clinical trials and post-marketing programs. The role involves working within a dedicated Benefit-Risk Management team and collaborating with cross-functional stakeholders to ensure compliance and timely delivery of safety outputs.
This position plays a key role in supporting pharmacovigilance system development, regulatory compliance, and lifecycle safety management for biosimilar products.
Key Responsibilities
Signal Management & Benefit-Risk Evaluation
Manage and oversee signal detection and evaluation activities.
Conduct benefit-risk assessments for clinical and post-marketing programs.
Monitor product safety profiles and emerging safety concerns.
Safety Reporting & Regulatory Intelligence
Prepare and manage aggregate safety reports including PADER, PSUR, and DSUR.
Conduct regulatory intelligence activities including legislation monitoring.
Ensure compliance with global reporting timelines and requirements.
Risk Management
Develop and maintain risk management strategies and plans.
Support implementation of risk minimization measures.
Monitor effectiveness of risk management activities.
Safety Systems & Lifecycle Management
Support setup, configuration, and validation of safety systems.
Manage system lifecycle activities as a subject matter expert.
Work with platforms such as Argus, ARISg, and Veeva Vault.
Process Development & Compliance
Develop, maintain, and optimize global PV processes.
Ensure compliance with international regulations including Food and Drug Administration, European Medicines Agency, and ICH guidelines.
Support continuous improvement of pharmacovigilance systems and workflows.
Cross-Functional Collaboration
Collaborate with PV teams, Medical Affairs, Regulatory, Quality, and IT.
Engage with external PV service providers and business partners.
Ensure alignment and timely delivery of safety deliverables.
Training, Audits & Inspections
Deliver training on pharmacovigilance processes and standards.
Support audits and regulatory inspections related to benefit-risk activities.
Ensure inspection readiness and compliance with audit requirements.
Required Skills
Pharmacovigilance Expertise
Strong experience in clinical and post-marketing pharmacovigilance.
Expertise in signal detection, benefit-risk evaluation, and safety reporting.
Understanding of global safety regulations and reporting standards.
Systems & Technical Knowledge
Experience with safety systems such as Argus, ARISg, and Veeva Vault.
Knowledge of PV system lifecycle management and validation.
Strong digital and data handling capabilities.
Regulatory & Compliance Knowledge
In-depth knowledge of global PV regulations including ICH, GVP, GCP, and CIOMS.
Understanding of regulatory frameworks such as Food and Drug Administration and European Medicines Agency.
Experience ensuring compliance in pharmacovigilance operations.
Communication & Leadership
Strong communication and interpersonal skills.
Ability to work independently and manage multiple priorities.
Experience working in global and cross-functional teams.
Preferred Qualifications
Experience with biologics or combination products.
Experience managing global product and study portfolios.
Experience in PV system implementation and transformation initiatives.
Key Competencies
Signal detection and benefit-risk assessment
Pharmacovigilance and safety reporting
Risk management and regulatory intelligence
PV systems and lifecycle management
Regulatory compliance (FDA, EMA, ICH, GVP)
Cross-functional collaboration and leadership
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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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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 :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
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 :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
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 :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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 :
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 :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
Switzerland | Faridabad | Thailand | Minnesota | Lousiana | Remote | Lenexa | Remote - Africa | Springville | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Victoria | Manipal | Nairobi | Ireland | Remote - South America (Latin Americal) | French | Texas | Tulsa | Bishop | Green Way | Xzagreb | McFarland | Bountiful | Hungary | Leinster | Zaragoza | Blue Bell | Riga | Castlebar | Belgium | Slovakia | Hammond | Medan | Remote - Europe | Melbourne | Remote, USA |Republic of Colombia :
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Ciudad de México | New Mexico |Dubai :
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Rabigh | King Abdullah Economic City | Jeddah | Riyadh | Najran | Khulais |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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