Experience

Regulatory Pharma Net - RPN

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Scientific Responsible Person, Quality assurance, Regulatory Affairs, PM, Drug Safety Consultant

  • Jan 2016 - Present

  My main responsibilities are within the following different areas:1) Project manager2) Expertise on promotional activities for medicinal products under prescription and SOP/OTC (e.g.social media)3) Scientific service responsible person (RSS):- supervision of the adherence to Italian regulations (congress sponsorship, advertising material revision, approval and submission and relevant follow up, update of PIL and labeling texts according to Italian rules developments); - revision/approval of non-promotional materials (market research, advisory board, etc) - check of sale representatives requirements; - revision/approval of sale representatives training material;- sale representative training execution; - preparation of technical specification for scientific service between parties; - communication of RSS to AIFA; - transmission of sale representatives data to AIFA;- accreditation/communication of sale representatives data to Italian Regions.4) Supervision PhV activities: - revision of safety agreements;- local sale forces training;- management of ICSRs and follow-up activities;- literature screening;- reconciliations;- other activities according to the SDEA into force between parties.5) Supervision of Medical Information requests:- management of medical information requests (collection, providing appropriate reply, filing; investigate for possible ICSR) - revision of specific SOP- training of field forces and internal staff 6) QA activities: - planning&performing internal and external audits;- Preparation and revision of internal&client’s SOPs;- Management of CAPAs;- risks assessment;- Involved during the third parties/authorities’ audits and ISO 9001:2015 certification.7) Consultancy on medical devices - Italian MoH database;- CE certificate; - technical file;- advertising material revision,submission to MoH;- revision of labeling; 8) Consultancy on cosmetics - revision of labeling texts- promotional materials revision



Pharmacy Minucci

• Pharmacist

  • Jan 2012 - May 2017



Abiogen Pharma S.p.a

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• QA GCP - GVP - ISF Officer

  • Sep 2013 - Jun 2015

  - Planning and execution of internal and external/third parties audits,- Selection and suppliers qualification,- Revision and preparation of documentation related to clinical trials (i.e. eCRF, protocol, IB, clinical supply, etc), Pharmacovigilance and Scientific Service carried out according to current legislation; - Preparation/revision of SOPs related to pharmacovigilance, GCP and scientific information service,- Training of the personnel involved in the processes, - Management of deviations and CAPA implementation- Involved in Authority inspections- Storage of SOPs and other documentation



Ethics Committee

• India
• Medical Practices
• 1 - 100 Employee

• Trainee

  • Feb 2013 - Jul 2013

  Study and evaluation of procedures and protocols related to clinical studies commissioned byvarious pharmaceutical companies. Study and evaluation of procedures and protocols related to clinical studies commissioned byvarious pharmaceutical companies.