Safety Systems Specialist (Pharmacovigilance Systems)
Location: Bangalore, India
Employment Type: Full-Time (Hybrid)
Job ID: 261413
Job Overview
The Safety Systems Specialist supports the implementation, configuration, maintenance, and migration of pharmacovigilance (PV) safety systems. The role ensures high-quality system operations and supports both internal and external clients in accordance with regulatory requirements and company SOPs.
This position plays a key role in ensuring safety systems are properly configured, validated, and maintained to support global drug safety operations.
Key Responsibilities
Safety Systems Configuration & Maintenance
Support implementation, configuration, and ongoing maintenance of safety databases and PV systems
Document system configurations and manage updates based on evolving requirements
Ensure compliance with validated system standards and regulatory expectations
Reporting & Data Management
Develop standard and ad hoc safety reports from PV systems
Perform data extraction for regulatory deliverables such as:
PSURs (Periodic Safety Update Reports)
DSURs (Development Safety Update Reports)
6-month safety listings
Support safety data reconciliation and reporting activities
System Support & Operations
Provide technical and functional support to end users and stakeholders
Handle ticket management, issue resolution, and escalation of system-related problems
Monitor system mailboxes for failures and ensure timely resolution
Respond to user queries and provide operational support
System Migration & Validation
Participate in system migration activities and related documentation
Perform User Acceptance Testing (UAT) and document results
Support system integration activities across PV platforms
Ensure proper validation and compliance of safety systems
Training & Change Management
Support training of end users and internal team members on safety systems
Assist with change management activities related to system updates
Provide peer support and knowledge sharing within the team
Compliance & Quality
Ensure adherence to SOPs, regulatory guidelines, and pharmacovigilance standards
Maintain high-quality execution of all assigned tasks
Stay updated on evolving PV regulations and system requirements
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 working with 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 understanding of pharmacovigilance systems and workflows
Proficiency in Microsoft Office tools
Strong communication skills (written and verbal)
Ability to manage multiple tasks and priorities
Logical thinking and problem-solving ability
Ability to work effectively in a team environment
Preferred Skills
Experience with SQL or basic database querying
Exposure to clinical or pharmacovigilance systems environment
Experience with ticketing/support tools (e.g., ServiceNow or similar)
Understanding of system integration concepts
Work Environment
Office-based or remote/hybrid working environment
Requires strong focus on detail and sustained system-based work
May involve handling multiple requests and system issues simultaneously
Role Summary
This role is critical in ensuring the stability, accuracy, and compliance of pharmacovigilance safety systems. It combines technical system support, regulatory awareness, and operational execution to enable efficient global drug safety processes.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra 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 :
Remote, 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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Concord | Lumberton | North Carolina |Michigan :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Hilo | Honolulu |Tennessee :
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Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
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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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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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 :
Breda |Noord Holland :
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 :
Richmond Hill | Australia | North York | Mississauga | Uxbridge | Renfrew |Canada :
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 :
Estonia | Tartu |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 :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Yavne | Tel Aviv | Kfar Saba | Be'Er Sheva | Netanya |Remote :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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King Abdullah Economic City | Riyadh | Rabigh | Najran | Jeddah | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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