Sitero is seeking an experienced Aggregate Report Specialist to join our Drug Safety Services team in Mysore, Karnataka. This role involves creating and quality-reviewing critical safety documents for both pre-marketing and post-marketing drug safety data. The specialist will support product development, regulatory submissions, and post-marketing surveillance while ensuring compliance with global pharmacovigilance regulations.
Key Responsibilities
✔ Authoring & Reviewing Aggregate Reports – Prepare and quality-check documents such as:
- PSURs (Periodic Safety Update Reports)
- PBRERs (Periodic Benefit-Risk Evaluation Reports)
- DSURs (Development Safety Update Reports)
- PADERs (Periodic Adverse Drug Experience Reports)
- ACOs (Addendum to Clinical Overviews)
- Canadian Annual Reports & Safety Update Reports
✔ Data Analysis & Interpretation – Evaluate clinical and non-clinical safety data from multiple sources.
✔ Literature Search & Review – Identify and summarize relevant medical literature for inclusion in reports.
✔ Regulatory Compliance – Ensure reports meet FDA, EMA, Health Canada, and other global regulatory requirements.
✔ Process Management – Maintain trackers, generate Periodic Safety Line Listings (PSLL), and handle regulatory/PRAC inquiries.
✔ Training & Mentorship – Guide junior pharmacovigilance associates and serve as a Subject Matter Expert (SME).
✔ Stakeholder Collaboration – Work closely with CROs, regulatory teams, and clients to resolve safety-related queries.
Education & Experience Required
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
- Minimum 5 years of experience in authoring aggregate reports, with at least 3 years in quality review.
- Strong knowledge of pharmacovigilance regulations (ICH-GCP, GVP, FDA/EMA guidelines).
Preferred Skills
- 5-8 years of experience in aggregate report writing & review.
- Proficiency in Microsoft Office (Word, Excel, Outlook).
- Excellent communication, organization, and multitasking abilities.
- Ability to work in shifts (if required) and meet tight deadlines.
- Experience in training & mentoring pharmacovigilance professionals.
Compensation & Benefits
- Competitive salary + Variable pay
- Healthcare & retirement benefits
- Paid time off & flexible work policies
- Opportunities for career growth
About Sitero
Sitero is a global leader in drug safety and pharmacovigilance services, providing end-to-end solutions for pharmaceutical and biotech companies. We specialize in regulatory compliance, risk management, and safety surveillance, ensuring patient safety and product efficacy.
