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Sitero, a global leader in clinical services and software solutions for the life sciences industry, is inviting applications for the role of Drug Safety Associate – Aggregate Reporting in Mysore, Karnataka.
This is an exciting hybrid opportunity for professionals passionate about pharmacovigilance, aggregate safety reporting, and regulatory compliance. If you’re skilled in PSURs, PBRERs, DSURs, and PADERs, this position offers a dynamic platform to grow in a collaborative, tech-driven environment.
🔹 Job Title: Aggregate Report Specialist (Drug Safety Associate)
🔹 Location: Mysore, Karnataka (Hybrid)
🔹 Department: Drug Safety Services
🔹 Company: Sitero
🔹 Employment Type: Full-Time
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Key Responsibilities
As a Drug Safety Associate – Aggregate Reporting, you will:
- Analyze, review, and interpret safety data from clinical and non-clinical studies.
- Author and quality review Aggregate Reports (PSURs, PBRERs, DSURs, PADERs, Annual Reports, ACOs).
- Conduct literature searches and summarize relevant safety articles.
- Manage trackers, listings, and reconciliation activities.
- Mentor and train pharmacovigilance associates.
- Support regulatory responses and PRAC inquiries.
- Collaborate with clients to ensure timely, compliant submissions.
- Participate in internal meetings, audits, and SOP-driven processes.
Qualifications and Experience
Education:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or an equivalent field.
Experience:
- Minimum 2 years of experience in authoring aggregate reports.
- At least 1 year of experience in quality reviewing aggregate reports.
Preferred Skills:
- Strong knowledge of pharmacovigilance regulations, epidemiology, and risk management.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent analytical, written, and verbal communication skills.
- Strong organizational skills with the ability to handle multiple deadlines.
Why Join Sitero?
- Work in a cutting-edge pharmacovigilance environment.
- Opportunity for career growth and training.
- Hybrid work model for better work-life balance.
- Exposure to global clinical safety operations and regulatory interactions.
- Collaborative and innovation-driven culture.
How to Apply
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