Junior Pharmacovigilance and Regulatory Affairs

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.