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- Drug Safety Associate / Safety Operations Specialist
Drug Safety Associate / Safety Operations Specialist
IQVIA Holdings Inc.
Petaling Jaya, Selangor, Malaysia
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.
Key Responsibilities:
- 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.
Key Requirements:
- 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.
Job posted: 2023-08-29