Apply now for Sitero Hiring for Drug Safety Associate – Aggregate Reporting. Explore exciting career growth in pharmacovigilance and drug safety.
Introduction
Sitero, a rapidly growing leader in clinical services and life sciences technology solutions, is inviting qualified professionals to join its Drug Safety Services team in Mysore, Karnataka. The organization has carved a niche in delivering high-quality, technology-enabled solutions that empower clients to focus on their core strengths. From early-phase studies to late-stage clinical trials, Sitero ensures ethical, compliant, and innovative approaches to advancing clinical research and safeguarding public health. Sitero Hiring for Drug Safety Associate
If you are a professional with a background in pharmacovigilance, life sciences, or pharmaceuticals and are seeking an opportunity to contribute meaningfully to drug safety and regulatory excellence, this position is designed for you. Sitero Hiring for Drug Safety Associate
About Sitero
Sitero stands at the forefront of clinical research and drug safety solutions, serving clients across various therapeutic areas. The company’s core mission is to deliver value-driven services that combine scientific expertise with cutting-edge technology. With a commitment to compliance, ethics, and innovation, Sitero ensures that its partners meet regulatory requirements and maintain the highest standards of safety for all stakeholders involved in clinical development. Sitero Hiring for Drug Safety Associate
Job Title:
AR Specialist (Aggregate Reporting)
Location: Mysore, Karnataka (Hybrid Work Mode)
Department: Drug Safety Services
Role Overview
As an Aggregate Report Specialist (AR Specialist), you will play a pivotal role in analyzing, interpreting, and reporting safety data across various stages of drug development and post-marketing surveillance. The role involves authoring, reviewing, and managing aggregate safety reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), and related regulatory submissions. Sitero Hiring for Drug Safety Associate
You will also collaborate closely with cross-functional teams, regulatory bodies, and clients to ensure that all safety documentation aligns with global pharmacovigilance regulations. Sitero Hiring for Drug Safety Associate – Aggregate Reporting
Key Responsibilities
1. Authoring and Reviewing Safety Reports
- Prepare and perform quality reviews for aggregate reports including PSURs, PBRERs, PADERs, DSURs, and Annual Reports.
- Develop responses to health authority queries and pharmacovigilance risk assessments.
- Author and review Risk Management Plans (RMPs), REMS, and related regulatory documentation.
2. Data Analysis and Interpretation
- Analyze and interpret safety data from clinical and non-clinical studies.
- Identify safety signals and trends through comprehensive data evaluation.
- Manage safety line listings and maintain data accuracy for periodic reports.
3. Literature Review and Research
- Conduct literature searches and summarize relevant safety publications for inclusion in regulatory reports.
- Ensure comprehensive coverage of recent scientific and clinical findings.
4. Compliance and Quality Management
- Adhere to Standard Operating Procedures (SOPs), Work Instructions, and company-specific compliance protocols.
- Ensure deliverables meet global regulatory and client requirements within the stipulated timelines.
5. Training and Mentorship
- Act as a Subject Matter Expert (SME) in aggregate reporting.
- Mentor and train pharmacovigilance associates and new team members.
- Contribute to internal safety and pharmacovigilance training sessions.
6. Client and Regulatory Collaboration
- Work closely with clients, CROs, and regulatory teams to resolve issues and ensure smooth report submissions.
- Support responses to inquiries from agencies such as Pharmacovigilance Risk Assessment Committee (PRAC) or local health authorities.
7. Documentation and Record Management
- Maintain rigorous document archiving as per internal policies.
- Manage process trackers to ensure transparency and accountability in project workflows.
8. Continuous Learning and Process Improvement
- Participate in refresher training programs and maintain up-to-date medical and regulatory knowledge.
- Contribute ideas for improving pharmacovigilance and safety documentation processes.
- Sitero Hiring for Drug Safety Associate
Education and Experience Requirements
- Educational Qualification:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related discipline. Equivalent qualifications in pharmacovigilance or biomedical sciences are also considered. - Experience:
- Minimum 2 years of experience in aggregate report authoring.
- At least 1 year of experience in quality reviewing aggregate reports such as PSURs, PBRERs, or DSURs.
Preferred Skills and Competencies
Sitero values professionals with a combination of analytical, technical, and communication skills. Ideal candidates should possess: Sitero Hiring for Drug Safety Associate – Aggregate Reporting
- Strong understanding of pharmacovigilance regulations and guidelines.
- Knowledge of epidemiology and biostatistics for interpreting safety data.
- Excellent documentation and report writing abilities with attention to detail.
- Good understanding of data retrieval systems and information management.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
- Ability to manage multiple projects under tight deadlines.
- Collaborative approach with strong interpersonal and team coordination skills.
- Flexibility to work extended or flexible hours to meet client or regulatory requirements.
- Innovative and proactive attitude toward problem-solving.
Why Join Sitero?
Working at Sitero means being part of a global team dedicated to advancing healthcare through data integrity, scientific excellence, and regulatory compliance. As part of the Drug Safety Services Division, you will gain exposure to international pharmacovigilance standards, diverse therapeutic areas, and cutting-edge safety assessment methodologies. Sitero Hiring for Drug Safety Associate
Benefits of Working at Sitero:
- Opportunity to work in a hybrid model with a balance of office and remote flexibility.
- Professional growth through continuous training and exposure to global projects.
- Collaborative work culture fostering innovation, ethics, and teamwork.
- Competitive compensation aligned with industry standards.
- Supportive leadership focused on career development and skill enhancement.
About the Work Environment
The Mysore facility offers a hybrid working environment that combines in-office collaboration with remote flexibility. The team comprises experienced professionals in drug safety, pharmacovigilance, and regulatory affairs who are passionate about patient safety and compliance excellence. Sitero Hiring for Drug Safety Associate – Aggregate Reporting
The role encourages collaboration across multiple teams, ensuring a rich learning experience and the opportunity to contribute to high-impact safety projects for global pharmaceutical clients. Sitero Hiring for Drug Safety Associate
Career Path and Growth Opportunities
As an Aggregate Report Specialist, you will develop expertise in global safety regulations, risk management, and aggregate reporting. This position can lead to advanced roles such as: Sitero Hiring for Drug Safety Associate – Aggregate Reporting
- Senior Aggregate Report Specialist
- Pharmacovigilance Project Manager
- Drug Safety Manager
- Regulatory Affairs Specialist
Sitero supports internal mobility, providing clear career advancement opportunities for high-performing employees.
Application Process
Interested candidates who meet the eligibility criteria can apply directly through Sitero’s career portal or relevant job platforms. Ensure that your resume highlights your pharmacovigilance experience, knowledge of aggregate reporting, and regulatory compliance expertise. Sitero Hiring for Drug Safety Associate
Applicants are encouraged to prepare examples of their previous work in report authoring or safety analysis to showcase their capability during the recruitment process.
Conclusion
If you are passionate about ensuring drug safety, maintaining regulatory excellence, and contributing to the healthcare industry’s most critical function—patient safety—then this opportunity at Sitero Mysore is the ideal next step in your career. Sitero Hiring for Drug Safety Associate
Join Sitero and become a part of a global team dedicated to driving innovation and safety in clinical research and pharmacovigilance.
Job Summary at a Glance:
- Position: Aggregate Report Specialist
- Department: Drug Safety Services
- Location: Mysore, Karnataka (Hybrid)
- Experience: 2+ years in authoring and quality review of aggregate reports
- Education: Life Sciences/Pharmacy degree or equivalent
- Key Skills: Pharmacovigilance, Aggregate Reporting, Regulatory Compliance, Risk Management
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