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Sitero, a fast-growing global clinical services and technology solutions company, is hiring an Aggregate Report Specialist for its Drug Safety function. This full-time, permanent, hybrid role is ideal for experienced pharmacovigilance professionals with strong expertise in aggregate safety reporting across clinical and post-marketing phases.
If you have hands-on experience in PSUR, PBRER, DSUR, PADER, and Annual Reports, and are looking to advance your career in drug safety and regulatory compliance, this opportunity at Sitero Mysore could be the right fit.
Job Overview
- Job Title: Aggregate Report Specialist
- Company: Sitero
- Function: Drug Safety / Pharmacovigilance
- Location: Mysore, Karnataka (Hybrid)
- Employment Type: Full-time, Permanent
- Experience Required: 5–8 years
Key Responsibilities
As an Aggregate Report Specialist at Sitero, you will be responsible for:
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- Authoring and quality review of Aggregate Safety Reports including:
- PSUR / PBRER
- DSUR
- PADER / Annual Reports
- Addendum to Clinical Overview (ACO)
- Performing integrated analyses of clinical and non-clinical safety data
- Conducting literature searches and summarizing relevant publications
- Generating Periodic Safety Line Listings (PSLL) from safety databases
- Managing and reconciling aggregate reporting trackers
- Responding to regulatory agency and PRAC safety queries
- Supporting ad-hoc and high-priority safety deliverables
- Collaborating with Regulatory Affairs, CRO partners, and internal PV teams
- Ensuring submissions comply with global pharmacovigilance regulations
- Training and mentoring pharmacovigilance associates
- Contributing to PV training programs and process improvements
Required Qualifications & Experience
Mandatory Requirements
- Minimum 5 years of experience in aggregate report authoring
- At least 3 years of Quality Review experience in aggregate reports
- Degree in Life Sciences / Pharmacy or equivalent
Preferred Profile
- 5–8 years of total experience in aggregate reporting
- Strong knowledge of global PV regulations and safety surveillance
- Exposure to regulatory authority interactions
- Proficiency in Microsoft Word, Excel, and Outlook
- Excellent written, verbal, and presentation skills
- Strong organizational, multitasking, and stakeholder management abilities
Compensation & Benefits
Sitero offers a competitive and employee-centric benefits package, including:
- Salary Range: ₹10,00,000 – ₹16,00,000 per annum (INR, industry-aligned)
- Performance-linked variable pay
- Paid time off and holidays
- Health insurance and retirement benefits
- Career growth in a global clinical research environment
Work Schedule & Commitments
- Standard 40 hours/week, Monday to Friday
- Flexibility to work extended hours or shifts based on client needs
- Hybrid work model
How to Apply
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