Sitero is a trusted partner for clinical research organizations and pharmaceutical companies worldwide, delivering high-quality solutions in clinical operations, pharmacovigilance, and regulatory compliance. With a focus on innovation, collaboration, and excellence, Sitero empowers its employees to drive positive change in healthcare and contribute to the safety and well-being of patients globally.
Key Responsibilities of the Aggregate Report Specialist
As an Aggregate Report Specialist at Sitero, you will play a pivotal role in supporting both pre-marketing and post-marketing safety activities. Your primary responsibilities include:
- Data Analysis and Interpretation:
- Review and analyze non-clinical, clinical, and other safety data to create comprehensive reports.
- Perform literature searches to incorporate relevant findings.
- Report Authoring and Quality Review:
- Author and review aggregate safety reports, including PSURs, PBRERs, PADERs, DSURs, and Canadian Annual Reports.
- Ensure compliance with global regulatory requirements.
- Process and Documentation Management:
- Generate Periodic Safety Line Listings (PSLL) from safety databases.
- Maintain and reconcile process trackers for streamlined operations.
- Subject Matter Expertise and Training:
- Act as a subject matter expert (SME) for safety reporting.
- Train and mentor junior pharmacovigilance associates.
- Client Interaction and Regulatory Support:
- Collaborate with clients to resolve report-related issues.
- Assist in handling regulatory agency inquiries, including those from the Pharmacovigilance Risk Assessment Committee (PRAC).
- Collaboration and Compliance:
- Work closely with regulatory affairs teams to ensure timely and accurate reporting.
- Support high-priority ad-hoc activities as required.
Qualifications and Experience
To excel in this role, candidates should meet the following criteria:
Educational Background:
- A degree in Life Sciences, Pharmacy, or a related field is required.
Experience:
- Minimum of 5 years of experience in authoring safety reports, with at least 3 years in quality review of aggregate reports.
- Preferred: 5-8 years of experience in report authoring and 3-5 years in quality review.
Skills and Competencies
- Proficiency in safety data analysis and regulatory reporting.
- Strong knowledge of drug safety and pharmacovigilance regulations.
- Expertise in Microsoft Office Suite (Outlook, Word, Excel).
- Excellent verbal and written communication skills.
- Strong organizational and multitasking abilities.
- Ability to build collaborative relationships across disciplines.
- Flexibility to adapt to changing priorities and work in shifts if needed.
- Innovative, proactive, and detail-oriented mindset.
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