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[Expired] Drug Safety Specialist

MICHAEL PAGE INTERNATIONAL (SINGAPORE)
Posted On :2 Sep 2013

 

Job Summary

  • 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

Job Descriptions

  • 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.

Job Description

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

Excellent package

Apply for this Job

Apply online using the apply button below or for more information phone Sophia Davison on +65 6533 2777 quoting job reference H1842070



About This Company