EVERSANA, a global leader in life sciences commercialization, is seeking a Safety Analyst to join its remote team in India. Known for delivering exceptional business results through innovative solutions, EVERSANA provides a dynamic work environment where employees can grow and thrive. Here’s everything you need to know about this exciting opportunity.
Company Introduction
EVERSANA is a global organization that partners with life sciences companies to bring critical therapies to market. From commercialization to patient services, EVERSANA’s comprehensive services empower clients to achieve better outcomes. The company is recognized for its commitment to innovation, integrity, and inclusion.
Responsibilities in the Job
As a Safety Analyst, you will play a pivotal role in supporting the Pharmacovigilance (PV) Department. Your key responsibilities include:
- Aggregate Safety Reporting: Managing the operational aspects of aggregate safety reporting, such as generating Periodic Adverse Drug Experience Reports (PADER).
- Data Compilation and Analysis: Compiling safety data from clinical trials, post-marketing reports, and other sources for compliance with regulatory requirements.
- Report Drafting: Assisting in drafting Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and other essential documents.
- Collaboration: Working closely with stakeholders to ensure accurate and timely submission of safety reports.
- Regulatory Compliance: Adhering to pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs).
- Process Support: Contributing to PV operations, audits, inspections, and drafting other safety deliverables.
Qualifications
The ideal candidate for this role should possess:
- A BS degree in a life science discipline, such as pharmacy or nursing (preferred).
- Broad knowledge of domestic and international drug safety regulations.
- Familiarity with safety databases (e.g., ARGUS, ARISg) and medical terminology.
- Understanding of ICH guidelines, drug safety reporting, and benefit-risk assessments.
- Strong attention to detail and quality orientation.
Skills
To excel in this position, you should have:
- Technical Expertise: Knowledge of safety databases and proficiency in Microsoft Office.
- Communication Skills: Ability to articulate ideas effectively and foster collaboration.
- Problem-Solving Skills: Capacity to transform creative ideas into impactful solutions.
- Ethical Standards: Demonstrated integrity and professionalism.
