Regulatory affairs/formação científica/sistema de gestão da qualidade

Regulatory Affairs /QPPV
1. Submission of new marketing applications for medicinal products and maintenance of the
Marketing authorisations already granted (quality and safety variations and renewal
applications);
2. Submission/notification for non-medicinal products: medical devices, food supplements and
cosmetics.
3. Looking for new products in order to increase the company´s portfolio;
4. Development of new products for company (food supplements);
5. Implementation of Ferraz Lynce’s Quality System;
6. Responsible for Ferraz Lynce’s Pharmacovigilance System.

Medical Affairs:
1. Research of published articles in literature/database, requested by health care professionals;
2. Scientific information/clarification to healthcare professionals and patients;
3. Sales representative training (pharmacological, pharmacokinetic and pharmacodynamic
information);
4. Marketing Department Support: Assessment of Monograph and promotional material’s review.
Preparation of scientific manuals.

Regulatory Affairs:
1. Preparation and submission of Marketing Authorization Holder Applications and line extensions by Mutual Recognition Procedure/ Decentralised procedure and National Procedure;
2. Preparation and submission of Type II variations (quality and safety) and Type I variations by Mutual Recognition Procedure/ Decentralised procedure and National Procedure;
3. Preparation and submission Marketing Authorization Holder Renewal Applications by Mutual Recognition Procedure/ Decentralised procedure and National Procedure;
4. Preparation of Standard Operation Procedures (SOPs) for Regulatory Affairs Department;
5. Preparation and Submission of Marketing Authorization Applications outside Europe: Angola, Mozambique and Cape Verde.

Responsible for pharmacovigilance:
1. Preparation and submission of Periodic Safety Update Report (PSURs);
2. Preparation and submission of CIOMs;
3. Responsible for Pharmacovigilance line (scientific, safety and efficacy questions about medicines marketed by Tecnifar, S.A.);
4. Eudravigilance database (loading and updating of database of Medicinal Products - Article 57);
5. Preparation and updating of Pharmacovigilance System Master File (PSMF);
6. Risk Management Plan (preparation and/or implementation of RMP and its minimisation measures);
7. Pharmacovigilance training of internal employee and force sale team.

Medical affairs:
1. Research of published articles in literature/database, requested by health care professionals;
2. Scientific information/clarification to healthcare professionals and patients;
3. Health Care professionals scientific and sales representative training (pharmacological, pharmacokinetic and pharmacodynamic information);
4. Marketing Department Support: Assessment of Monograph and promotional material.
5. Launch of new products in following therapeutic areas: Central Nervous System (Alzen SR, Trazone OD and Striatal), Respiratory area (Assieme and Birresp) and Women heath (Oral emergency contraception – EllaOne).

Technical director support:
1. Technical verification of batches produced by Tecnifar´s manufactures,
2. Preparation and update of Standard Operation Procedures for Technical Director Department

Regulatory Affairs:
1. Preparation and submission of Marketing Authorization Holder Applications by Mutual
Recognition Procedure and National Procedure;
2. Centralised Procedures;
3. Preparation and submission of Type II variations (quality and safety) and Type I variations Mutual Recognition Procedure and National Procedure;
4. Preparation and submission of Marketing Authorization Holder Renewal Applications by Mutual Recognition Procedure and National Procedure;
5. Preparation of Periodic Safety Update Report (PSUR’S) for Renewal applications;
6. Marketing Department Support.

Technical director adjunct of Bayer Portugal, S.A.,
1. Technical verification of batches produced by Bayer´s Manufactures;
2. Preparation and update of Standard Operation Procedures for Technical Director Department.