About this role
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
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.
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE: Full Time, Permanent
COMMITMENTS:
• Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
• Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.