Position Title: Drug Safety Associate – Aggregate Reporting
Job Title: Aggregate Report (AR) Specialist
Function: Drug Safety Services
Location: Mysore, Karnataka (Hybrid)
Organization: Sitero
Job Category: Pharmacovigilance / Drug Safety
About Sitero
Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. With expertise across diverse therapeutic areas, we deliver technology-enabled, ethical, and compliant solutions that empower clients to focus on their core strengths.
Our experienced teams support Phase I–III clinical trials with high-touch services and advanced technologies—ensuring the safety of all stakeholders in the clinical research ecosystem.
Position Overview
The Aggregate Report Specialist is responsible for creating and quality reviewing aggregate safety reports and related documentation for both pre-marketing and post-marketing safety data. These reports support product development, regulatory submissions, and post-marketing maintenance activities.
The role requires strong medical and pharmacovigilance knowledge, analytical skills, and expertise in regulatory reporting standards and risk management.
Key Responsibilities
Core Duties
Analyze, interpret, and review clinical and non-clinical safety data from various sources.
Author and review aggregate safety reports such as:
PSUR / PBRER
PADER
DSUR
Addendum to Clinical Overviews (ACO)
Annual Reports
RMP / REMS
Health authority responses and safety assessments
Conduct literature searches and present relevant articles for inclusion in reports.
Generate Periodic Safety Line Listings (PSLL) from safety databases.
Manage and reconcile process trackers to ensure compliance with project timelines.
Provide subject matter expertise (SME), training, and mentoring to junior associates.
Handle regulatory inquiries, including those from Pharmacovigilance Risk Assessment Committee (PRAC).
Provide support for ad-hoc safety-related activities as prioritized by clients or internal teams.
Collaborate with Regulatory Affairs to ensure accurate and timely submission of safety data.
Compliance & Documentation
Ensure deliverables comply with regulatory requirements and are submitted within agreed timelines.
Adhere to company SOPs, work instructions, and quality systems.
Maintain internal documentation archives as per defined procedures.
Complete mandatory training programs within designated timelines.
Collaboration
Participate in internal and client meetings as required.
Actively engage in knowledge sharing and continuous process improvement.
Collaborate across departments and with external stakeholders to achieve project goals.
Education and Experience
Required Qualifications:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
Minimum 2 years of experience in authoring aggregate safety reports, with at least 1 year of experience in quality review of such reports.
Preferred Qualifications:
2+ years of experience in authoring and reviewing PSURs, PBRERs, DSURs, or equivalent regulatory reports.
Strong understanding of drug safety and pharmacovigilance concepts, epidemiology, and biostatistics.
Familiarity with global regulatory requirements and signal management processes.
Skills and Competencies
Excellent attention to detail and documentation accuracy.
Strong analytical and problem-solving abilities.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Excellent written and verbal communication skills.
Ability to work independently and collaboratively across teams.
Skilled in time management and handling evolving deadlines.
Knowledge of data storage, retrieval systems, and literature databases.
Flexible to work extended or variable hours based on client needs.
Proactive, innovative, and solution-oriented mindset.
Key Attributes
Strong commitment to ethics, compliance, and patient safety.
A collaborative team player with mentoring and leadership potential.
Adaptable and open to continuous learning and process improvement.
Work Environment
Hybrid model: Combination of remote and on-site work at Mysore, Karnataka.
Must adhere to Sitero’s Health, Safety, and Quality procedures at all times.
Gujarat :
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