PV Coordinator – FSP (Fully Remote)
Job Details
Job Title: PV Coordinator – FSP
Location: Hyderabad, India (Fully Remote)
Job Type: Full-Time
Work Schedule: Standard (Monday–Friday)
Job ID: R-01362187
Experience & Salary
Experience: 1+ years in Pharmacovigilance (PV) Case Processing (Argus database experience mandatory)
Salary: As per company standards / Not disclosed
Job Summary
Join a global pharmacovigilance team supporting leading pharmaceutical and biotechnology companies. The role involves coordinating safety activities, managing adverse event documentation, supporting Data Safety Monitoring Boards (DSMBs), Endpoint Adjudication Committees (EACs), and ensuring regulatory compliance across global clinical programs.
Key Responsibilities
Coordinate the review of serious and non-serious adverse events, protocol inquiries, diagnostics, and DSMB data.
Track safety data and generate reports for clients, project teams, and vendors.
Coordinate DSMB and EAC meetings, including logistics, documentation, and meeting facilitation.
Prepare Confidentiality Disclosure Agreements (CDAs), Letters of Intent (LOIs), and Member Agreements.
Compile adjudication dossiers and manage follow-up with investigative sites.
Organize project meetings, prepare meeting minutes, and distribute documentation.
Maintain project files and ensure audit readiness.
Redact subject identifiers according to data privacy requirements and coordinate site retraining when necessary.
Perform data entry, system reconciliations, and maintain tracking databases.
Monitor project budgets, oversee expenses, and coordinate translation activities.
Handle hotline calls and support department operations.
Assist with local office activities when required.
Provide training and guidance to junior team members.
Eligibility Criteria
Graduation in Life Sciences preferred.
Minimum 1 year of Pharmacovigilance Case Processing experience.
Experience with the Argus Safety Database is mandatory.
Equivalent education, training, and relevant experience may also be considered.
Required Skills
Strong problem-solving and analytical abilities.
Ability to work independently with minimal supervision.
Excellent relationship-building and communication skills.
Proficiency in MS Office (Word, Excel, PowerPoint, Access).
Strong organizational and multitasking skills with attention to detail.
Ability to manage multiple priorities under strict deadlines.
Professional attitude and adaptability in changing work environments.
Knowledge of FDA Regulations, ICH-GCP, SOPs, and pharmacovigilance processes.
Working Conditions
Office-based, fully remote work environment.
Extensive computer-based work.
Occasional travel to site locations if required.
Flexibility to work extended hours during project demands.
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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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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 :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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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 | Uxbridge | North York | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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