Monica M. Email and Phone Number

Currently working as a contractor for ICON/Takeda and performing: signal detection, signal evaluation activities (internal, WHO, FAERS, EVDAS), aggregate reports review, PQR and HHE writing, RA website reviewWorked as a contractor for Allergen/Abbvie and performed the following activities: signal detection, signal validation and signal evaluation, HHEs and aggregate reports planning, compilation and review.

Pharmacovigilance DepartmentIndividual case processing in Eudravigilance. Review of Risk Management Plans.Participation in the MRP and DCP regulatory procedures.Used the EPITT and Article 57 databases.

Clinical Trial UnitClinical trial authorisation requests validation and evaluation. Substantial and non-substantial amendments evaluation. Authorisation of clinical trial medical facilities.Writing and reviewing of Standard Operating Procedures.

Individual case processing in Actavis database. Performing case review.

Ensured that the activity in the pharmaceutical warehouse complies with the GDP guidelines and national legislation.

Pharmacist responsible with the management of controlled substances with medical use in the warehouse.

Dispensing pharmaceutical products to the patients and providing counseling in the community pharmacy.