Safety Systems Associate II – Pharmacovigilance Systems (PSS)
Location: Bangalore, India
Employment Type: Full-Time
Job ID: 261659
Job Overview
The Safety Systems Associate II supports the implementation, configuration, maintenance, and migration of pharmacovigilance (PV) safety systems. The role ensures smooth system operations for internal and external clients while maintaining compliance with regulatory standards and internal SOPs.
This position combines technical system support with pharmacovigilance operations to ensure the integrity, accuracy, and reliability of safety systems used in global drug safety reporting.
Key Responsibilities
Safety Systems Configuration & Support
Perform configuration and maintenance of safety systems based on project requirements
Maintain and document system configurations and updates
Support system implementation, upgrades, and migration activities
Ensure compliance with validated system standards and regulatory requirements
Reporting & Data Operations
Develop standard and ad hoc reports from safety databases
Perform data extraction for regulatory deliverables including:
PSURs
DSURs
6-month safety listings
Support routine and ad hoc safety data reporting activities
System Support & Issue Management
Provide technical and functional support to end users
Manage ticketing systems, troubleshoot issues, and escalate when required
Monitor system mailboxes for failures and resolve issues promptly
Respond to user queries and provide operational assistance
Testing, Migration & Validation
Participate in data migration activities and documentation
Perform User Acceptance Testing (UAT) and complete required documentation
Support system integration and validation activities
Ensure accuracy and compliance throughout system changes
Training & Knowledge Sharing
Support training of users and internal team members on PV systems
Assist in change management activities
Provide peer support and share technical knowledge within the team
Compliance & Quality
Ensure adherence to SOPs, work instructions, and pharmacovigilance regulations
Maintain high-quality standards in all deliverables
Stay updated on current PV regulatory requirements
Ensure timely escalation of system and process issues
Qualifications
Degree in Life Sciences or IT/Computer Science preferred
Equivalent experience may be considered in lieu of a formal degree
Minimum 2+ years of experience in drug safety systems (e.g., Argus, ARISg, Veeva Safety, or similar platforms)
Required Skills & Competencies
Experience in system support or operations roles
Strong attention to detail and accuracy
Good communication skills (written and verbal)
Ability to manage multiple priorities effectively
Strong problem-solving and logical thinking skills
Proficiency in Microsoft Office tools
Ability to work independently and in team environments
Preferred Skills
Understanding of SQL or basic database querying
Experience with ticketing systems (e.g., ServiceNow or similar)
Exposure to clinical or pharmacovigilance environments
Knowledge of system integration concepts
Work Environment
Office-based or remote/hybrid setup
Requires focus on system operations and troubleshooting tasks
May involve handling multiple concurrent system issues
Role Summary
This role supports pharmacovigilance safety systems through configuration, maintenance, reporting, and issue resolution. It is a technical-operational position focused on ensuring system reliability and regulatory compliance within global drug safety operations.
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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Hajipur | Patna |Kerala :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |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 :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Buenos Aires |Republic of Egypt :
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