Aggregate Safety Report Writer

Education and Experience:

• Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience OR Life Science degree and 1 year of pharmacovigilance experience

• Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job

Knowledge, Skills and Abilities:

• Our ideal candidate will have a minimum of two years’ experience in authoring two or more of the following report/document types for medicinal products:

o DSUR (Development Safety Update Report)

o PBRER / PSUR (Periodic Benefit Risk Evaluation Report / Periodic Safety Update Report)

o PA(D)ER (Periodic Adverse [Drug] Experience Report)

o RMP (Risk Management Plan)

• Good understanding and knowledge of aggregate safety report writing guidelines, and clinical trial and post-marketing pharmacovigilance legislation in relation to medicinal products.

• Experience of authoring medical device aggregate safety reports or clinical evaluation reports is preferable, although not essential.

• Task based project management experience and experience with interacting directly with internal and/or external stakeholders.

How to apply:

Please submit your CV in English.

Registration on our website will also give you the opportunity to be considered for other positions if this one is not the most appropriate for your qualifications and experience.

Only short-listed candidates will be contacted.

PPD is an equal opportunities employer

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