Freyr Solutions
Website:
freyrsolutions.com
Job details:
As an Associate or Senior Associate- Pharmacovigilance Global Regulatory Intelligence, you would support safety intelligence and surveillance activities by monitoring public-domain sources, health authority communications, scientific literature, regulatory updates, and safety-related information to identify emerging risks, safety signals, and regulatory trends.
Key Responsibilities
Safety Intelligence & Monitoring
- Monitor global health authority websites, regulatory agencies, and public databases for safety-related updates.
- Track adverse drug reaction communications, recalls, label changes, safety alerts, and risk minimization measures.
- Review scientific literature, conference proceedings, and medical publications for product-specific safety information.
- Conduct routine surveillance of public-domain safety information.
- Surveillance of Health care professional letters, signal evaluation and assessments.
Data Analysis & Reporting
- Analyze safety trends and emerging risks across products, therapeutic areas, and markets.
- Prepare safety intelligence summaries and executive dashboards.
- Identify potential safety signals from publicly available information.
- Support trend analysis using internal and external datasets.
Knowledge Management
- Classify and tag safety-related content.
- Maintain pharmacovigilance knowledge repositories.
- Support metadata management and content categorization.
Required Skills
- Understanding of pharmacovigilance concepts and safety lifecycle.
- Experience reviewing regulatory and safety-related content.
- Strong analytical and research skills.
- Familiarity with MedDRA and safety terminology.
- Familiarity with global regulations in the pharmaceutical and/ or medical device industry is an added advantage
- Ability to coordinate with stakeholders from multiple functions
- Good English communication and interpersonal skills
- A customer-first attitude
- Problem-solving aptitude
- Ability to work well with a team
Click on Apply to know more.