Drug Safety Associate / Safety Operations Specialist
As our business grows, we are looking to further strengthen our Safety Operations team by hiring a number of Drug Safety Associate in IQVIA Malaysia.
You will 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 Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.
- To Prioritize and complete the assigned trainings on time.
- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information
- Determining initial/update status of incoming events
- Database entry
- Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- Ensure to meet the expected productivity, quality standards and delivery standards per project requirements.
- Identify quality problems, if any, and bring them to the attention of a senior team member.
- To mentor new teams members, if assigned by the Manager.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- Perform other duties as assigned.
- High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences
- Bachelor's degree in life sciences or healthcare related field.
- Good knowledge of medical terminology.
- Working knowledge of applicable Safety Database and any other internal/Client applications.
- Knowledge of applicable global, regional, local clinical research regulatory requirements.
- Excellent attention to detail and accuracy, maintain high quality standards.
- Good working knowledge of Microsoft Office and web-based applications.
- Self-motivated and flexible.
- Attention to detail and accuracy.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Ability to manage competing priorities and deadlines.
- Willingness and aptitude to learn new skills across Safety service lines.
- Strong time management skills.
- Ensure quality of deliverables according to the agreed terms.
- Flexibility to operate in shifts.
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