Drug safety specialist

Randstad Belgium

Full time |  Permanent  |  3 year  |  Salary type not mentioned Salary not mentioned  |  1 Jobs  | English,French

Job Description

Drug safety specialist

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Randstad professionals: a reliable partner in recruiting ICT, Life Sciences, engineering, HR, sales & marketing and Finance specialists. For a renowned consultancy company based in Limburg, Randstad Professionals is recruiting a drug safety specialist.



As a drug safety specialist you have the following responsibilities:

Ensure that all safety data are efficiently handled and submitted within the legally defined timelines and according to SOP's
Ensure compliance with the conditions of the Marketing Authorization, and the Marketing Authorization holder or its Distributor, and interact with other departments' such as RA
Demonstrate expertise within the area of Vigilance (Pharmacovigilance and Materiovigilance)
Ensure an adequate and unambiguous operational filing and tracking system
To assist , review or write PSUR's
Develop and provide Vigilance training to customers and staff
Hands on experience with Eudravigilance
To be part of the Vigilance team
Presence during Vigilance audits/inspections and involvement in interactions and communication with auditors/ inspectors
Manage non-conformities and CAPA


Master or Ph. D. in Pharmacy or Sciences
At least 3 years' experience in Safety and or Vigilance ,within the pharmaceutical industry
Team player with demonstrated attitude of reliability and attention to detail and good organizational skills
Able to adapt your behavior to different work situations
Willing to learn, take initiative and be proactive
Having good problem solving capabilities, analytical thinking, pragmatic
Proficiency in the required software and computer skills
Regulatory Affairs experience is not a must but an asset
Excellent written and verbal communication skills in English, Dutch and French

Our Offer:

Our client offers a dynamic and supportive working environment and a range of development challenges and opportunities. They also offer competitive benefits and compensation packages.



Master or Ph. D. in Pharmacy or Sciences

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