- Salary: Undisclosed
- Work Type: Permanent / Full Time
- Min. Education Level: Degree
- Field of Study: Life Sciences
- Years of Experience: 1
- Skills: Pharmacovigilance regulations and guidelines, pharmacological and medical terminology, Interpersonal and Communication skills
- Impressive portfolio of life saving drugs
- World leading Pharmaceutical Group
About Our Client
Our client is a world leading pharmaceutical company with global presence. They are focused on discovering, developing and bringing to market innovative products covering a wide range of therapy areas.
This individual will be responsible for supporting drug safety processes and ensuring compliance to external and internal standards. This will involve:
- Managing the processing, documentation, reporting and follow-up of all serious and non-serious adverse event reports from clinical trials, Patient Programs, post-marketing studies and Spontaneous Reports.
- Accurately and consistently updating all adverse event data onto safety systems with an emphasis on meeting timelines and quality requirements.
- Recording and tracking receipts, submissions and distributions of Adverse Events, Investigator Notifications, Periodic Safety Report Updates and any other relevant data.
- Ensuring appropriate reporting and submission/distribution of safety reports to Local Health Authorities and clinical operations.
- Communicating with any relevant external and internal bodies and health authorities to exchange relevant safety information
- Survey and monitor national Pharmacovigilance regulations and provide updates to global teams.
- Develop, update and implement local procedures to ensure compliance with internal and external requirements.
The Successful Applicant
- Bachelors Degree in life sciences, pharmaceutical sciences or a related discipline. PhD or MD is an advantage.
- At least 1 years Drug Safety experience in a Pharmaceutical or CRO setting.
- Understanding of local and global Pharmacovigilance regulations and guidelines.
- Demonstrated ability to complete tasks to a high quality and meet strict timelines .
- Knowledge of pharmacological and medical terminology.
- Excellent communications, interpersonal and negotiation skills
What's On Offer
Apply for this Job
Apply online using the apply button below or for more information phoneSophia Davison on +65 6533 2777 quoting job referenceH1842070