• Junior Pharmacovigilance and Regulatory Affairs (M/F/D) Portugal
  • HAYS in Portugal, , Portugal
  • jobs
  • 3 weeks ago

jobs description

Descrição da Função

Your new company
Multinational company in health area.
Your new position
Pharmacovigilance:- Post-marketing safety case handling;- Literature review (of the results sent by the external vendor);- Monitoring of regulatory submissions PV related;- Submission of PV clinical documentation to CA (SUSAR reports and DSURs);- Elaboration of SUSAR line listings for the site initiation visit (SIV);- Audits support;- Customer Service Support;Regulatory Affairs:- Support MS submissions (DCP Submissions, variations within deadline defined);- Support regulatory database updates;- Support to raise packaging materials (review/approval);- Support to translation of regulatory documents (labelling).
What do you need to be succeed
- Degree in pharmaceutical sciences;- Fluent in Portuguese and English (written & spoken);- Knowledge of windows software;- Proactivity and accountability mindset;- Team-work spirit;- Detail-oriented and sense of organization.
What the company can offer... you
We are offering a base salary, meal allowance and a monthly award, with a temporary contract of 1 year with the possibility to renovate for the same period. You will have a hybrid work and a flexible schedule.
License 354
Next Steps
If you are interested in this job, please send us your update CV.

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