Junior Pharmacovigilance And Regulatory Affairs
3 semanas atrás
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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