PHARMAFull-time
Pharmacovigilance Reporting Associate
By Admin · Pharmacovigilance & Drug Safety
BANGALORE (IN)REMOTEPOSTED: 9/30/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE OVERVIEW
Supports accurate and timely preparation, review and submission of pharmacovigilance safety reports for clinical trials and post-marketing activities. The role combines safety-report preparation, adverse-event data analysis, regulatory compliance and cross-functional collaboration.
ROLE DEFINITION & RESPONSIBILITIES
- •Prepare and review periodic safety updates and Individual Case Safety Reports
- •Collect and analyze adverse-event data from clinical-trial and post-marketing sources
- •Ensure safety reports are accurate, complete and compliant with regulatory standards
- •Maintain current knowledge of pharmacovigilance reporting requirements and industry practices
- •Collaborate with clinical, regulatory and data-management teams to obtain information and resolve reporting issues
- •Submit safety reports to regulatory authorities and sponsors within established deadlines
- •Manage multiple reporting activities and prioritize deliverables in a regulated environment
Reporting Hierarchy: Reports to pharmacovigilance/drug-safety reporting leadership; Collaborates with clinical, regulatory and data-management teams and external sponsors/regulatory authorities
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Life Sciences, Pharmacy or a related field
- Experience in pharmacovigilance or drug safety
- Strong understanding of safety reporting processes and regulatory requirements
- Strong attention to detail and organizational skills
- Strong communication and multidisciplinary collaboration skills
- Ability to manage multiple tasks and priorities
- Legal right to work in India
PREFERRED QUALIFICATIONS
- •Experience with periodic safety reports and ICSR reporting
- •Clinical-trial and post-marketing pharmacovigilance experience
- •Knowledge of global pharmacovigilance regulations
- •Experience working with clinical, regulatory and data-management functions
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Drug Safety
Safety Reporting
Periodic Safety Updates
ICSR
Adverse Event Data
Clinical Trial Safety
Post-Marketing Safety
Regulatory Compliance
Safety Report Preparation
Safety Report Review
Regulatory Submissions
Sponsor Communication
Cross-functional Collaboration
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Bonus & Equity: Performance-related incentives
Benefits: Competitive base salary and performance-related incentives, health and wellbeing programs, medical/dental/vision coverage where applicable, retirement and pension plans, life assurance and disability coverage, employee assistance programs, learning and development opportunities
The posting states that ICON offers a competitive base salary and performance-related incentives but does not disclose numeric salary figures. Health and other benefits vary by role and location.
ORGANIZATION CONTEXT & CULTURE
ICON is a global healthcare intelligence and clinical research organisation supporting the development of new medicines and treatments. Its work spans clinical research and healthcare services, with a focus on quality, collaboration and patient impact.
TEAM SIZE: 40,000+ employees globally
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
Culture: ICON describes a values-driven culture centered on integrity, collaboration, agility, inclusion and professional development.
EXPECTED CAREER ROADMAP
Potential progression includes Senior Pharmacovigilance Reporting Associate, Safety Reporting Specialist or Lead, and broader Pharmacovigilance Operations or Drug Safety management roles.
APPLICATION ADVISORY
Emphasize pharmacovigilance or drug-safety experience; highlight ICSR and periodic safety-report preparation/review; demonstrate knowledge of regulatory reporting requirements; show experience analyzing adverse-event data; highlight accuracy, deadline management and cross-functional collaboration; mention willingness to travel approximately 10%.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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