Safety Operations Specialist in Regulatory Reporting
IQVIA Safety Operations – Regulatory Reporting team play an important part in execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. Each new joiner is supported by a nurturing management team, collaborative colleagues as well as a clear career ladder with plenty of opportunities to allow you to grow, adapt and shine.
We are looking for the best talent, with English language expertise to be part of a global team that partnership with a major pharmaceutical company, working with patient safety on post-market products. Apply your knowledge and expertise, including complex decision making, to review, assess and process safety and product quality information.
Safety Operations Specialist in Regulatory Reporting with English language
Review, assess and process safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties, following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
- Process safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- Perform Pharmacovigilance activities per project requirement; collecting and tracking incoming Adverse Events(AE)/endpoint information, determining initial/update status of incoming events.
- Receive, review and interpret medical reports.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- Assure compliance to all project related processes and activities.
- Create, maintain and track cases as applicable to the project plan.
- Prioritize and complete the assigned trainings on time.
- Identify quality problems and bring them to the attention of a senior team member.
- Code AE and Products, write narratives and perform Literature related activities as per internal/ project timelines.
- Attend project team meetings and provide feedback to operations manager on any challenges or successes.
Minimum Required Education and Experience
- Must be fluent in English language (min. C1)
- Bachelor’s Degree in Life Sciences or Healthcare discipline is a must.
Skills and Abilities
- Excellent attention to detail and accuracy.
- Good knowledge of medical terminology.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Effective verbal and written communication skills.
- Ability to manage competing priorities.
- Strong presentation skills; report writing skills and customer focus skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
- Self-motivated and flexible.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com