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.

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.