Aggregate Report Specialist
Department:
Drug Safety Services
Employment Type:
Full-Time
Minimum Experience:
Mid-level
Location:
Mysore, Karnataka
Description:
The Aggregate Report Specialist is responsible for creating and quality reviewing documents related to both pre-marketing and post-marketing safety data to support product development, license applications, and post-marketing maintenance activities. Key deliverables include integrated analyses of safety data for aggregate reports such as DSURs, PSURs/PBRERs, PADERs, Safety Update Reports, and responses to regulatory safety queries. The specialist works closely with safety teams across Sitero, CROs, and partner organizations to ensure regulatory compliance and the highest quality of reporting.
Essential Duties and Responsibilities:
Analyze, review, and interpret non-clinical and clinical safety data and other relevant sources.
Author and review aggregate reports including PSURs/PBRERs, PADERs, Annual Reports, ACOs, and DSURs.
Perform literature searches and incorporate findings into aggregate reports.
Manage and reconcile relevant process trackers.
Serve as a Subject Matter Expert (SME), providing training and mentoring to team members.
Generate Periodic Safety Line Listings (PSLL) from safety databases.
Handle regulatory agency and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
Provide reliable support for high-priority ad-hoc activities.
Interact with client personnel to resolve issues related to aggregate reports according to client policies.
Ensure deliverables comply with relevant regulatory requirements and are submitted within agreed timelines.
Contribute to pharmacovigilance and drug safety training programs.
Collaborate with Regulatory Affairs to ensure appropriate pharmacovigilance reporting.
Train and mentor Pharmacovigilance Associates.
Education and Experience Required:
Degree in Life Sciences, Pharmacy, or equivalent.
Minimum 5 years of aggregate report authoring experience, with at least 3 years in quality review.
Preferred Skills:
5-8 years of aggregate report authoring experience with 3-5 years in quality review.
Proficiency with Microsoft Office Suite (Outlook, Word, Excel).
Strong verbal, written, and interpersonal communication skills.
Excellent organizational and prioritization abilities with multitasking capability.
Flexibility to meet fluctuating business priorities.
Willingness to occasionally work extended and flexible hours to meet client needs.
Strong relationship-building and collaboration skills across disciplines.
Innovative and proactive mindset.
Compensation and Benefits:
Sitero offers a competitive salary, variable pay, paid time off, and healthcare and retirement benefits.
Employment Type:
Full-Time, Permanent
Commitments:
Standard working hours: 40 hours per week, Monday to Friday, with a one-hour lunch break.
Willingness to work in shifts if required.
Disclaimer:
Sitero is an equal opportunity employer. All qualified applicants will be considered without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or other legally protected factors.
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