Eversana, a global leader in life sciences services, is hiring Safety Analyst Interns, Safety Writing Specialists (2–4 yrs), and Senior Safety Writing Specialists (4+ yrs). These roles are ideal for professionals looking to advance their careers in pharmacovigilance, aggregate safety reporting, and risk management writing.
If you have strong communication skills, experience in PV safety reports, and the drive to deliver client delight, Eversana offers an excellent opportunity to grow your career in a global healthcare environment.
📝 Job Responsibilities
Safety Analyst (Intern)
- Support pharmacovigilance operational delivery for client projects.
- Assist in preparing aggregate safety reports (PADER, DSUR, PSUR/PBRER, ASR, IND reports).
- Generate line listings and compile safety data from trials and post-marketing sources.
- Draft sections of safety reports and risk management materials.
- Ensure compliance with regulatory requirements and timelines.
- Collaborate with cross-functional PV teams.
Safety Writing Specialist (2–4 years)
- Author and finalize aggregate reports (PADER, DSUR, PSUR/PBRER, ASR, IND).
- Contribute to Risk Management Plans (RMPs), PSMF, and PV risk management documents.
- Work with sponsors/clients during audits, inspections, and CAPA management.
- Interpret and synthesize safety data for regulatory submissions.
- Support PV operations and SOP development.
Senior Safety Writing Specialist (4+ years)
- Lead and manage aggregate report writing and safety document authoring.
- Oversee team allocation and mentor junior writers.
- Review, maintain, and refine PV procedural documents.
- Handle RMPs and advanced PV documentation with regulatory authorities.
- Drive process improvements in aggregate reporting and PV compliance.
✅ Qualifications
- For Interns: Life sciences, pharmacy, or biomedical graduates. Knowledge of PV regulations and safety databases (ARGUS/ARISg) preferred.
- For Specialists (2–4 yrs): Experience in aggregate safety reports, MedDRA coding, client interactions, and RMP authoring.
- For Senior Specialists (4+ yrs): Proven expertise in PSUR/PBRER/RMP, team handling, and PV compliance with audits/inspections.
- Strong communication, analytical, and documentation skills are a must.
🎯 Why Join Eversana?
- Opportunity to work with a global leader in pharmacovigilance and safety writing.
- Exposure to diverse client projects and international regulatory standards.
- Collaborative work culture with mentorship and growth opportunities.
- Competitive salary package (₹4 LPA – ₹15 LPA depending on role and experience).
📩 How to Apply
Interested candidates can share their CVs with gulafsha.bhatt@eversana.com.
