Technical Director, Local Responsible for Pharmacovigilance, Regulatory Affairs Manager Portugal

Job description

Title: Technical Director, Local Responsible for Pharmacovigilance, Regulatory Affairs Manager Portugal Company: Ipsen Produtos Farmaceuticos SA About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: At Ipsen, we believe that patients cannot wait to receive the right treatment, support, and awareness they need. Therefore, our goal is to make a difference by significantly improving the health and quality of life of patients and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases. The patient is at the center of everything we do, and we also care about our employees because they are the ambassadors and the ones who truly make a difference. We attract and develop bold, agile, and entrepreneurial people who take full responsibility for their decisions; leaders drawn to the purpose of making a direct impact through their work on people's lives. We offer employees a wealth of rewarding challenges and growth opportunities, and the chance to contribute within a constantly moving organization, an organization that truly changes the game. At Ipsen, we are looking for a Technical Director, Local Responsible Person for Pharmacovigilance (LPVM), Regulatory Affairs Manager Portugal, based in Lisbon, who, under the direction of the Technical Director Spain. Regulatory, Quality, Pharmacovigilance and Medical Information Lead Ipsen Iberia, will act as: As Technical Director To comply with the legal responsibilities as Technical Director of the Ipsen Portugal in relation to the activities of Marketing Authorization Holder (MAH), Storage and Distribution of medicines and medical devices, according to the European and local legislation, namely Decree-Law no. 176/2006, of 30 August, with the changes introduced in the meantime, including, without limitation, by Decree-Law 20/2013 , of 14 February (hereinafter referred to as “DL 176/2006”) and Deliberation no.047/CD/2015, which establishes good distribution practices of medicines for human use (“Good Distribution Practices”), with permanent and continuous dedication. As Local PV Manager Manage Local Pharmacovigilance (PV) activities in-country according to the role of the Local PV manager (LPVM) defined in Ipsen Global Standard Operating Procedures (SOPs) and to the Good Clinical Practices (GCPs)/Good Pharmacovigilance Practices (GVPs) and to the national legislation • Act as National PV contact / Local Qualified Person for Pharmacovigilance • Ensure local PV process are updated and inspection ready • Be a point of contact for Global Patient Safety (GPS) in Portugal As Regulatory Affairs Manager To compile, elaborate and revise all documentation to submit the Marketing Authorization Applications (MAAs), Marketing Authorization (MA) variations and renewals to the Health Authorities, in accordance with the Ipsen procedures and local guidance. Revision of the promotional activities of the products in charge of generated by the marketing & medical department in accordance with the Local Regulation, Code of Conduct and Ipsen policies. As Technical Director, Local PV Manager and Regulatory Affairs Manager: to act as the main contact point with the Portuguese Competent Authorities. Who are we looking for? Requirements: Knowledge & Experience (essential): Experience in a similar position with a proven experience in Technical Director or Deputy (GDPs): experience in maintaining Quality Management System, auditing Regulatory Affairs (management of lifecycle of pharmaceutical products: national, mutual recognition, decentralized and centralized procedures, revision of promotional/non-promotional materials and activities) Pharmacovigilance (experience acting as local PV or deputy) Demonstrated experience acting as the primary point of contact with National Health Authotities in Portugal Approximately 1-2 years in similar position Knowledge & Experience (preferred): Experience in a similar position with a proven experience in Technical Director or Deputy (GDPs): experience in maintaining Quality Management System, auditing Regulatory Affairs (management of lifecycle of pharmaceutical products: national, mutual recognition, decentralized and centralized procedures, revision of promotional materials and activities) Pharmacovigilance (experience acting as local PV or deputy) Demonstrated experience acting as the primary point of contact with National Health Authotities in Portugal Approximately 2-3 years in similar position Education / Certifications (essential): Degree in Pharmaceutical science with accredited training on GDPs and GVPs Education / Certifications (preferred): Master in Pharmaceutical Industry and Postgraduation in Quality, Pharmacovigilance and Regulatory Affairs of the Pharma Industry Language(s) (essential): Expert/fluent communicator in Portuguese and English. Level required for medical translation of safety reports and information Language(s) (preferred): Expert/fluent communicator in Portuguese and English. Level required for medical translation of safety reports and information Knowledge of Spanish is a valuable asset Competencies: Drive Purpose: Puts values and ethics at the forefront of everything; Anchors Ipsen's purpose, mission and commitments to patients and society. Manage Complexity: Identifies contradictory information/demands/inputs to effectively solve problems; Develops and evaluates alternative scenario and solutions; Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact. Mindfulness Risk-taking: Methodically assesses, transparently shares, and makes risk-informed decisions; Empowers to take ownership and accountability. Excellence in execution: Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society; Able to be focused and performance-driven with clear KPIs Plans and aligns effectively (steps, resources, timelines etc.) Displays a commitment to best practice sharing and setting What do we offer? Joining Ipsen means becoming part of a global biopharmaceutical group focused on innovation and specialized care in three key therapeutic areas: oncology, neurosciences, and rare diseases. Ipsen's Human Resources policy pays special attention to ensuring that all employees have good working conditions, including a flexible working hours model, training and development programs, as well as social benefits and competitive remuneration based on three main principles: internal equality, external competitiveness, and recognition of work. TYPE OF CONTRACT Permanent – Full-time We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solut