Aggregate Report Specialist

Aggregate Safety Reports:

• Analyzes, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources
• Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR, health authority responses) for submission to local and other Health Authorities`
• Performing literature search and presentation of relevant articles for the aggregate reports.
• Management and reconciliation of relevant process trackers
• Subject matter expert (SME) along with training and mentoring of individuals
• Generation of Periodic Safety Line Listings (PSLL) from safety database
• Exposure in handling regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
• Providing reliable support for high priority Ad-hoc activities
• Interacting with appropriate client personnel to resolve issues related to the Aggregate reports as per clients’ policies
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines
• Contributes to safety and pharmacovigilance training programs
• Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
• Attend internal and technical team meetings as required.
• Training and mentoring of Pharmacovigilance associates.

Miscellaneous:

• Maintain rigorous adherence to written procedures, e.g., SOPs/Work instructions
• Adherence to Company Health & Safety procedures
• Participate in refresher training programmes.
• Should archive all documents internally as per procedure.
• Should complete all trainings on or before due date in relevant training platforms.
• Any other duties as assigned by your manager.

Education and Experience Required:

• Minimum 1-3 years of experience in authoring of Aggregate Reports
• Degree in Life Science/Pharma or Equivalent

Preferred Skills:

• Preferred: 1-3 years of experience in authoring of Aggregate Reports
• Knowledge of principles of epidemiology and statistics
• Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies.
• Good documentation practice
• Knowledge and information sharing
• Excellent attention to detail
• Proficient computer knowledge and computer keyboarding skills.
• Proficient with Microsoft Office Suite (Outlook, Word, Excel, PPT).
• Strong verbal, written and interpersonal communication skills.
• Flexibility to adapt and meet fluctuating business priorities.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
• Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
• Innovative, collaborative, initiative-taker.
• Understanding of the principles of information storage and retrieval and skill in their application
• A solutions provider with strong multi-tasking abilities
• Manage evolving deadlines effectively with regular feedback and updates.
• Enthusiasm and drive to take ownership and drive process initiatives.