Job Title: Coordinator – Pharmacovigilance
Location: India (Remote Work Available)
Department: Safety and Vigilance / Drug Safety
Employment Type: Permanent
Experience Required: 3–4 Years in Pharmacovigilance Workflow or Case Management
Role Overview
The Coordinator – Pharmacovigilance plays a critical role in supporting drug safety operations by monitoring pharmacovigilance workflows, managing case processing activities, and ensuring the efficient allocation of tasks across safety teams. This position focuses on optimizing workflow performance, ensuring timely completion of pharmacovigilance activities, and supporting operational coordination across safety, regulatory, and technical teams. The role requires strong analytical capabilities, regulatory knowledge, and experience in pharmacovigilance case management systems.
Key Responsibilities
Pharmacovigilance Workflow Monitoring
Monitor real-time performance of pharmacovigilance workflow systems to ensure optimal resource allocation.
Track task and job progress to ensure adherence to project timelines and regulatory deadlines.
Identify workflow bottlenecks and recommend improvements to enhance operational efficiency.
Case Management and Task Coordination
Ensure appropriate allocation of pharmacovigilance tasks to qualified team members or functional groups.
Oversee workflow case management activities to ensure compliance with safety reporting timelines.
Coordinate activities across drug safety teams to maintain continuous case processing operations.
Cross-Functional Collaboration
Work closely with development, safety operations, and technical teams to ensure workflows meet business and regulatory requirements.
Support communication between operational teams and system users to resolve workflow challenges.
Assist in aligning pharmacovigilance operations with regulatory reporting standards.
Technical Support and Training
Provide operational and technical support related to workflow systems and case processing tools.
Deliver cross-training and knowledge sharing sessions to improve team efficiency and process understanding.
Assist team members in troubleshooting workflow issues.
Performance Analysis and Process Improvement
Analyze workflow performance data to identify opportunities for operational improvements.
Support implementation of process enhancements that improve efficiency and compliance.
Document processes and operational guidelines for pharmacovigilance workflow management.
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline.
Advanced degrees in pharmacovigilance, regulatory affairs, or clinical research are considered an advantage.
Experience Requirements
Minimum 3–4 years of experience in pharmacovigilance workflow management or safety case processing.
Hands-on experience with pharmacovigilance databases and workflow management systems.
Required Technical Skills
Strong knowledge of pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).
Understanding of FDA regulations and safety requirements for pharmaceutical and cosmetic products.
Knowledge of adverse event reporting processes and causality assessment principles.
Experience reviewing and interpreting Safety Data Exchange Agreements (SDEAs) or Pharmacovigilance Agreements (PVAs).
Proficiency in Microsoft Office tools including Excel, Word, and PowerPoint.
Core Competencies
Strong analytical and problem-solving skills with the ability to work under tight deadlines.
Effective communication and documentation abilities for cross-functional collaboration.
Strong project coordination and organizational skills.
Ability to make operational decisions and manage workflow priorities.
High attention to detail and accountability in safety operations.
Preferred Skills
Experience working with pharmacovigilance databases or safety workflow management systems.
Strong database management or data analysis experience.
High emotional intelligence and adaptability in a fast-paced regulatory environment.
Excellent organizational, time management, and teamwork skills.
Work Environment
This role supports remote or distributed work environments and requires strong collaboration with global pharmacovigilance and safety teams to ensure continuous monitoring and compliance of safety reporting activities.
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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Siliguri |Illinois :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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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Amsterdam |North Brabant :
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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 :
North York | Mississauga | Richmond Hill | Uxbridge | Renfrew | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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