PSPM Support Associate (Pharmacovigilance Support)
Location: Bangalore, India
Employment Type: Full-Time
Job ID: 262083
Job Overview
The PSPM Support Associate supports Clinical Safety and Post-Marketing Safety (PSS) operations, including adverse event processing from clinical trials and post-marketing sources.
The role ensures accurate, timely, and compliant handling of safety data, including submission to clients and regulatory authorities as required, while adhering to applicable SOPs, global regulations, and company quality standards.
Key Responsibilities
Study & Project Support
Support setup, maintenance, and close-out of global or regional safety projects
Assist the Global Safety Lead in preparation of:
Safety Management Plans (SMPs)
Reconciliation Plans
Other safety-related documentation
Support development of job aids, training materials, and templates
Assist in system setup and ongoing maintenance during study lifecycle
Support access management, training assignments, and other functional tasks
Safety Data & Reporting Support
Assist in reconciliation of safety databases, where applicable
Support preparation of monthly and study-specific safety reports
Ensure accuracy and quality of safety metrics and data reporting
Assist in drafting and updating safety presentations for internal and external stakeholders
Support compliant safety reporting aligned with global regulatory requirements
Documentation & Compliance
Assist in TMF (Trial Master File) management activities
Support preparation of documentation for audits (internal, client, or regulatory)
Maintain understanding of SOPs and controlled safety documentation
Ensure adherence to pharmacovigilance processing guidelines and regulations
Collaboration & Communication
Work closely with Global Safety Leads and cross-functional teams
Demonstrate strong teamwork and peer support
Communicate effectively with internal stakeholders
Follow escalation pathways when required
Qualifications
Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field preferred
Equivalent combinations of education and experience may be considered
Experience Requirements (any one combination):
Non-degree + 1 year safety experience (or 3 years relevant experience)
Associate degree + 1 year safety experience (or 2 years relevant experience)
Bachelor’s degree + 1 year relevant experience
Master’s/PharmD + 1 year relevant experience (PharmD fellowship may be considered equivalent)
Required Skills & Competencies
High attention to detail and accuracy
Strong written and verbal communication skills
Ability to work independently with moderate supervision
Strong teamwork and collaboration skills
Proficiency in Microsoft Office tools
Ability to manage routine operational tasks efficiently
Basic mentoring/support capability (preferred)
Work Environment
Office-based or remote working environment
Requires focus, accuracy, and ability to manage structured workflows
May involve repetitive, deadline-driven operational tasks
Role Summary
This role supports pharmacovigilance operations by assisting in adverse event processing, safety reporting, and project coordination activities. It is an entry-to-mid level support position focused on operational execution, compliance, and documentation within global drug safety systems.
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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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Lake Charles | Shreveport |Nevada :
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Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Washington |Delaware :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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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 :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
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Bucharest |Buenos Aires :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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King Abdullah Economic City | Riyadh | Rabigh | Najran | Jeddah | Khulais |Kuala Lumpur :
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Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sweden |Taipei :
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