Sitero Pharmacovigilance Jobs: Aggregate Report Specialist

Sitero Pharmacovigilance Jobs: Aggregate Report Specialist – Mysore (Life Sciences/Pharma Graduates

Explore Sitero Pharmacovigilance vacancies in Mysore for Life Sciences and Pharma graduates. Apply for Aggregate Report Specialist roles. Minimum 5 years’ experience required.

Sitero Pharmacovigilance Careers 2025: Hiring Aggregate Report Specialists in Mysore

Are you passionate about drug safety and pharmacovigilance? Sitero, a global leader in clinical research and safety services, is inviting experienced Life Sciences or Pharma graduates to apply for the role of Aggregate Report Specialist based in Mysore, Karnataka. If you have a minimum of 5 years of experience and a solid background in pharmacovigilance documentation, this opportunity is crafted for you!

About Sitero

Sitero provides high-quality, end-to-end solutions in clinical development, regulatory affairs, and pharmacovigilance services. With a focus on innovation, integrity, and client-centric operations, Sitero has built a reputation for delivering top-notch services across the healthcare and life sciences industries.

Current Opportunity: Aggregate Report Specialist

Sitero is seeking qualified and motivated professionals to join its Drug Safety Services team. As an Aggregate Report Specialist, you will be responsible for drafting, reviewing, and finalizing critical pharmacovigilance documents, ensuring regulatory compliance and supporting global safety reporting activities.

Key Responsibilities

• Analyze, review, and interpret safety data from non-clinical and clinical sources.
• Author and quality review Aggregate Reports including DSURs, PADERs, PSURs, PBRERs, and Annual Reports.
• Conduct literature searches and integrate findings into safety reports.
• Manage safety data trackers and generate Periodic Safety Line Listings (PSLL).
• Act as a Subject Matter Expert (SME) and mentor junior associates.
• Handle regulatory inquiries and contribute to risk management activities.
• Ensure timely and compliant submissions to clients and regulatory authorities.
• Collaborate with Regulatory Affairs teams to ensure accurate pharmacovigilance reporting.

Educational Qualifications

• Degree in Life Sciences, Pharmacy, or an equivalent discipline is mandatory.

Experience Requirements

• Minimum 5 years of experience in authoring pharmacovigilance reports.
• Minimum 3 years of experience in Quality Review of Aggregate Reports.
• Preferred: 5-8 years of total experience in aggregate report writing and review.

Desired Skills

• Proficiency with Microsoft Office Suite (Word, Outlook, Excel).
• Strong verbal and written communication skills.
• Excellent organizational, prioritization, and multitasking abilities.
• Ability to work flexible schedules and meet business priorities.
• Innovative, collaborative, and self-driven approach to work.

Location

• Mysore, Karnataka

Employment Type

• Full-time, Permanent

Work Commitments

• 40 hours per week, Monday to Friday.
• Flexibility to work in shifts if required.

Application Process

Interested candidates can apply directly through Sitero Careers.

Quick Overview Table

Disclaimer: Sitero is an equal opportunity employer and encourages applications from all backgrounds