Global Submissions Associate (ICSR / Case Finalization)
Company: Vizen Life Sciences
Location: Hyderabad, Telangana, India
Job Type: Full-Time (Work From Office)
Department: Pharmacovigilance / Drug Safety
Experience: 1–2 Years
About the Role
Vizen Life Sciences is hiring a Global Submissions Associate to support Individual Case Safety Report (ICSR) submissions and case finalization activities within the Pharmacovigilance function. The role involves managing regulatory submissions, ensuring compliance with global safety reporting requirements, and supporting timely case processing activities.
Key Responsibilities
ICSR Submission Management
Perform global ICSR submission activities in accordance with regulatory requirements.
Ensure timely and accurate submission of safety cases to health authorities and business partners.
Review cases prior to submission to ensure completeness and compliance.
Case Finalization
Perform case quality review and finalization activities.
Verify case accuracy, consistency, and regulatory compliance.
Ensure all required documentation is completed before case closure.
Regulatory Compliance
Maintain compliance with global pharmacovigilance regulations and company SOPs.
Support submission tracking and reconciliation activities.
Assist with audit and inspection readiness activities.
Database & Documentation Management
Maintain accurate case records within safety databases.
Support submission documentation and reporting activities.
Ensure proper filing and archival of safety-related records.
Required Qualifications
Education
Bachelor's or Master's Degree in:
Pharmacy
Life Sciences
Biotechnology
Microbiology
Related Healthcare Discipline
Experience
1–2 years of experience in:
Global ICSR Submissions
Pharmacovigilance Operations
Case Processing
Drug Safety
Required Skills
Pharmacovigilance (PV)
Global ICSR Submissions
Case Finalization
Drug Safety
Regulatory Compliance
Safety Databases
Medical Terminology
Quality Review
Case Reconciliation
Documentation Management
Attention to Detail
Communication Skills
Work Location
Hyderabad, Telangana
Work From Office (WFO)
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Delhi | Gangtok | 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) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Dickinson |Minnesota :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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 | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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Ho Chi Minh City |Italy :
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
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