Pharmacovigilance Information Specialist GPIO (PVIS)

at  Parexel

SKILLS:

• Sound knowledge of expedited and periodic drug safety reports required by RA, EC and Investigators
• Sound knowledge of the drug development process
• Knowledge of and ability to interpret and apply global safety regulations
• Experience in reading/ researching legislations and guidance documents
• Good presentation/ verbal and written communication skills
• Analytical and problem-solving skills
• Excellent interpersonal skills
• Excellent organizational and prioritization skills
• Ability to work collaboratively and effectively in a team environment
• Client focused approach to work
• Experience with computer applications including database management

Knowledge and Experience:

• Experience working on reporting expedited or periodic safety reports to Regulatory Authorities/ Ethics committees or Investigator is preferable, or experience with processing safety reports in the safety database.
• Experience with clinical trial or post market drug safety studies/ projects.

EDUCATION:

• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
• Associates/diploma degree in any of the above with appropriate work experience

Parexel are looking for a Pharmacovigilance Information Specialist (PVIS) for the GPIO (Global Pharmacovigilance Information Office) based in the Dublin, Ireland office. This role will research, review, and maintain information related to expedited and periodic safety reporting requirements for both clinical trial studies and post market projects.
The PVIS works to ensure company and client compliance with relevant national and regional drug/ device safety regulations and Standard Operating Procedures (SOPs).