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Sitero, a leading global provider of clinical, regulatory, and pharmacovigilance services, is hiring Aggregate Report Specialists for its Mysuru (Hybrid) location. This opportunity is ideal for professionals with 1โ3 years of experience in aggregate report authoring and quality review, particularly in PSUR, PBRER, DSUR, and PADER preparation.
If you are seeking to build a strong career in pharmacovigilance, drug safety, and regulatory medical writing, this role offers exposure to global safety teams, regulatory interactions, and career growth in a highly specialized domain.
๐ Job Overview
- Job Title: Aggregate Report Specialist
- Company: Sitero
- Location: Mysuru, Karnataka (Hybrid)
- Experience: 1โ4 Years
- Employment Type: Full-Time, Permanent
- Openings: 2
๐งพ Key Responsibilities
- Analyze, review, and interpret non-clinical and clinical safety data.
- Author and quality review Aggregate Reports including:
- PSUR / PBRER
- DSUR
- PADER / Annual Reports
- Addendum to Clinical Overview (ACO)
- Perform literature searches and summarize relevant safety publications.
- Generate Periodic Safety Line Listings (PSLL) from safety databases.
- Handle regulatory authority and PRAC inquiries.
- Maintain trackers, reconcile data, and ensure on-time submissions.
- Collaborate with Pharmacovigilance, Safety, and Regulatory Affairs teams.
- Train and mentor pharmacovigilance associates.
- Ensure compliance with ICH, GCP, and global PV regulations.
๐ Qualifications & Experience
- Degree in Life Sciences / Pharmacy (B.Pharm, M.Pharm, MSc, PharmD, or equivalent).
- 1โ3 years of experience in aggregate report authoring.
- Minimum 1 year experience in quality review of aggregate reports.
- Strong knowledge of pharmacovigilance regulations and safety surveillance.
- Proficiency in MS Word, Excel, and Outlook.
- Excellent written, verbal, and interpersonal communication skills.
๐ผ Preferred Skills
- Hands-on experience with PSUR, PBRER, DSUR, PADER.
- Ability to multitask and meet tight timelines.
- Strong organizational and documentation skills.
- Client interaction and issue resolution capabilities.
๐ฐ Compensation & Benefits
- Competitive salary package (โน8โ10 LPA, as per industry standards)
- Variable pay
- Paid time off
- Healthcare & retirement benefits
- Hybrid working model
๐ Why Join Sitero?
- Work with global safety and regulatory experts
- Strong learning and career progression in pharmacovigilance
- Exposure to international regulatory submissions
- Collaborative and inclusive work culture
๐ฅ How to Apply
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