Sitero is hiring for an Aggregate Report Specialist in its Drug Safety Services department in Mysore, Karnataka. The position is offered as a hybrid, full-time, permanent role and requires experience in authoring aggregate safety reports, including PSURs/PBRERs, PADERs/Annual Reports, ACO, and DSURs.
Job Details
| Details | Information |
|---|---|
| Company | Sitero LLC |
| Position | Aggregate Report Specialist |
| Department | Drug Safety Services |
| Location | Mysore, Karnataka |
| Work Mode | Hybrid |
| Employment Type | Full-Time, Permanent |
| Experience | 1–3 years in authoring Aggregate Reports |
| Qualification | Degree in Life Science/Pharma or Equivalent |
| Work Schedule | Monday–Friday, 40 hours per week |
| Shifts | Willingness to work in shifts as needed |
Position
Aggregate Report Specialist
The role involves analyzing and interpreting safety data, authoring and reviewing aggregate safety reports, performing literature searches, managing report-related trackers, and supporting pharmacovigilance activities and regulatory requirements.
Key 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, ACO, and DSURs.
- Prepare responses to Health Authority requirements.
- Perform literature searches and present relevant articles for aggregate reports.
- Manage and reconcile relevant process trackers.
- Generate Periodic Safety Line Listings (PSLL) from the safety database.
- Handle regulatory agency and PRAC inquiries.
- Provide support for high-priority ad-hoc activities.
- Resolve aggregate report-related issues with appropriate client personnel.
- Ensure deliverables meet relevant regulatory requirements and agreed timelines.
- Contribute to pharmacovigilance and safety training programs.
- Collaborate with Regulatory Affairs on pharmacovigilance and drug safety information reported to regulatory agencies and the prescriber community.
- Train and mentor Pharmacovigilance associates.
- Maintain adherence to SOPs and work instructions.
- Complete required training within applicable timelines.
- Archive documents according to procedures.
Eligibility & Qualifications
Candidates should have:
- 1–3 years of experience in authoring Aggregate Reports.
- A degree in Life Science, Pharma, or equivalent.
Required Skills
- Knowledge of epidemiology and statistics principles.
- Working knowledge of relevant information sources, including publications, unpublished sources, databases, websites, internal departments, and external bodies.
- Good documentation practices.
- Strong information-sharing capabilities.
- Excellent attention to detail.
- Proficiency with Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.
- Strong verbal, written, and interpersonal communication skills.
- Ability to adapt to changing business priorities.
- Ability to work extended or flexible schedules when required.
- Strong collaboration and relationship-building skills.
- Ability to manage multiple tasks and evolving deadlines.
- Understanding of information storage and retrieval principles.
- Ability to take ownership and drive process initiatives.
Work Schedule
The position follows 40 hours per week, Monday through Friday, with a one-hour lunch period. Additional hours may be required, and candidates should be willing to work in shifts as needed.
Application Details
Position: Aggregate Report Specialist
Location: Mysore, Karnataka (Hybrid)
Department: Drug Safety Services
Employment Type: Full-Time, Permanent