PHARMAFull-time
Pharmacovigilance Reporting Specialist
By Admin · Pharmacovigilance & Drug Safety
BANGALORE (IN)REMOTEPOSTED: 9/8/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE OVERVIEW
Pharmacovigilance Reporting Specialist responsible for accurate and timely safety reporting and regulatory compliance. The role covers PSURs, ICSRs, safety-data analysis, adverse-event reporting and collaboration across drug-safety stakeholders.
ROLE DEFINITION & RESPONSIBILITIES
- •Prepare and submit comprehensive safety reports including PSURs and ICSRs
- •Analyze pharmacovigilance data to identify trends and assess pharmaceutical-product safety profiles
- •Collaborate with cross-functional teams to ensure timely and accurate adverse-event reporting
- •Maintain current knowledge of pharmacovigilance regulations and industry best practices
- •Ensure reporting activities comply with regulatory standards and internal policies
- •Take ownership of assigned pharmacovigilance deliverables and maintain high quality standards
- •Provide training and support to team members on pharmacovigilance reporting processes and requirements
Reporting Hierarchy: Reports to pharmacovigilance/drug-safety management; Collaborates with cross-functional clinical, safety and regulatory stakeholders
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Significant experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment
- Strong analytical skills and proficiency with data-analysis tools and reporting software
- Excellent written and verbal communication skills
- Ability to maintain high standards of quality and regulatory compliance
PREFERRED QUALIFICATIONS
- •Experience with additional pharmacovigilance databases and safety-reporting systems
- •Knowledge of international pharmacovigilance regulations and reporting requirements
- •Experience providing process training or mentoring to drug-safety team members
REQUIRED VERIFIED SKILLS
Pharmacovigilance
drug safety
PSUR
ICSR
adverse-event reporting
safety-data analysis
regulatory compliance
pharmacovigilance regulations
reporting software
quality assurance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Bonus & Equity: Performance-related incentives
Benefits: Competitive base salary and performance-related incentives; Health and wellbeing programmes including applicable medical, dental and vision coverage; Retirement and pension plans; Life assurance and disability coverage; Employee assistance programmes and wellbeing resources; Learning and development opportunities through structured training and career pathways
The posting does not disclose a specific salary range. It explicitly mentions a competitive base salary and performance-related incentives, but no numerical compensation figures are provided.
ORGANIZATION CONTEXT & CULTURE
ICON is a global healthcare intelligence and clinical research organisation focused on accelerating the development of medicines and treatments for patients.
TEAM SIZE: 40,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
Culture: Values-driven culture emphasizing integrity, collaboration, agility, inclusion and meaningful contributions to patients, customers and healthcare development.
EXPECTED CAREER ROADMAP
The role can progress toward Senior Pharmacovigilance Specialist, Pharmacovigilance Lead, Safety Reporting Manager, Drug Safety Manager or broader pharmacovigilance leadership and regulatory-safety positions.
APPLICATION ADVISORY
Emphasize hands-on pharmacovigilance and drug-safety reporting experience; Highlight PSUR and ICSR preparation or submission experience; Mention relevant regulatory knowledge and safety-reporting systems; Demonstrate analytical ability through safety-data and trend-analysis examples; Highlight cross-functional communication, quality and compliance ownership; Include experience training or supporting colleagues where applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.