Senior Pharmacovigilance Specialist
Location: India
Employment Type: Full-Time
About ProPharma
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, medical device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies.
ProPharma partners with clients through an Advise-Build-Operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers end-to-end consulting solutions that de-risk and accelerate critical drug and device development programs.
Role Summary
The Senior Pharmacovigilance Specialist is responsible for overseeing and performing daily case processing activities for adverse event reports from clinical trials and post-marketing sources. The role involves case assessment, coding, narrative writing, quality review, client communication, mentoring team members, and ensuring compliance with global pharmacovigilance regulations.
Key Responsibilities
Case Processing & Safety Management
Oversee and perform daily processing of adverse event cases from clinical trial and post-marketing sources.
Code adverse events and medical information using MedDRA.
Determine seriousness, expectedness, and reportability at both event and case levels.
Conduct case follow-up activities and identify missing information required for complete case assessment.
Create and review case narratives to ensure medical accuracy and regulatory compliance.
Provide client notifications as required for case management activities.
Highlight discrepancies, concerns, or quality issues related to ICSRs to senior management.
Quality & Compliance
Perform peer review of cases to ensure quality, consistency, and accuracy.
Maintain up-to-date knowledge of global pharmacovigilance regulations and industry standards.
Provide pharmacovigilance subject matter expertise and oversight for assigned deliverables.
Conduct Healthcare Professional (HCP) reviews as required.
Training & Mentorship
Support the development of training materials and training delivery initiatives.
Mentor and train junior team members and less experienced staff.
Contribute to knowledge sharing and continuous improvement within the pharmacovigilance function.
Additional Responsibilities
Perform other pharmacovigilance-related duties as assigned.
Required Skills & Competencies
Strong verbal, written, and interpersonal communication skills.
Intermediate project management capabilities.
High level of accuracy and attention to detail.
Strong problem-solving and analytical skills.
Ability to work independently and collaboratively within cross-functional teams.
Excellent organizational, prioritization, and multitasking abilities.
Intermediate knowledge of Pharmacovigilance principles and processes.
Working knowledge of safety databases, including:
Oracle Argus Safety
ARISg
Other Pharmacovigilance Safety Systems
Educational Requirements
Required
Bachelor's Degree in Life Sciences
Preferred
Advanced Degree
Registered Nurse (RN)
Registered Pharmacist (RPh)
PharmD or equivalent qualification
Experience Requirements
Minimum 3 years of relevant Pharmacovigilance experience
Experience in:
ICSR Processing
MedDRA Coding
Case Narrative Writing
Safety Data Review
Regulatory Compliance
Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote 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 :
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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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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 :
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Ho Chi Minh City |Italy :
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Saitama | Japan |Tokyo :
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Kyiv |Lima Region :
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