Deputy Local Safety Officer
hace 3 semanas
This position primarily serves as Deputy Local Safety Officer (LSO) for our Spanish and Italian Affiliates and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV systems are operating appropriately by executing operational PV tasks.
Act as the Deputy of the National PV Contact Persons in Spain and Italy.
This position will act as a back-up for the LSOs to support their implementation of the DSE PV policy strategy, assuring the local PV system is operating appropriately by overseeing and executing operational PV tasks in Spain and Italy.
The individual will be accountable for liaising with other DSES and DSIT stakeholders (e.g. Regulatory, Medical Affairs, Marketing) as well as local PV vendors, and providing PV Training to the relevant local functions and external parties as necessary to ensure PV processes are implemented properly.
This position will report to the Local Safety Officer in Spain and is expected to work independently with minimal guidance with specialized knowledge, and use expertise to analyze and solve problems.
Roles and Responsibilities Act as back-up of the primary contact point/nominated person for pharmacovigilance for the Spanish and Italian Health Authorities. Responsible for supporting the LSOs in performing/overseeing all local PV activities in Spain and Italy. Supports the LSOs in ensuring safety report collection process is implemented and oversees the processes are working properly. Involved in creating and updating local procedures in line with regulatory requirements and European PV processes. Responsible for acting as contact person for pharmacists, physicians, and consumers for the reporting of adverse events (AEs) and Product Technical Complaints (PTCs) to collect safety information and their follow-up activities. Performs/oversees local literature screening, monitoring of local PV legislation, and implementation of Risk Management Plans (RMPs) and additional Risk Minimization Measures at a local level as required. Liaises with local stakeholders (e.g. Medical, Marketing) as well as local PV vendors, and providing PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly (e.g. Market Research Programs). Contributes to the maintenance of the EU Pharmacovigilance System Master File (PSMF) by providing up-to-date information from the local PV system. Contributes to the company's benefit-risk evaluation for Daiichi Sankyo products and to answering requests from Competent Authorities. Acts as a key contributor for the GVP affiliate audits/inspections in Spain and Italy. PV process enhancement: Contributes to the enhancement of EU affiliates PV Quality Management System standards by providing the inputs from local PV Systems. Facilitates the local implementation of global processes (e.g. management of the collection of adverse events, PV regulatory intelligence, management of Safety Data Exchange Agreements). Vendor/Partner oversight: Implements/maintains PV agreements/SDEAs with local partners/PV service providers working with internal subject matter experts (SMEs) ensuring all PV requirements are covered in the contract. Maintain contract template as current. Coordinates periodic communications with partners and ensure the contract is up-to-date and the process is operating well (e.g. PV service providers, Market research vendors) and ensure periodic reconciliations are carried out. Oversees the activities of the PV vendor support. Skills and Additional Requirements Previous experience in Pharmacovigilance activities in the Spanish PV affiliate, experience within Italy is advantageous. Bachelor's degree in Life Sciences, Pharmacy or Medical Sciences with post graduate qualification preferred. Possesses strong knowledge of International, European and local PV laws and guidance. Considerable pharma organisation awareness (interrelationship of departments, business priorities, including significant experience working cross-functionally). A focus on accuracy and integrity. Analytic and systematic approach with good problem-solving skills. Ability to understand complex matters with a continuous focus on improvement. Strong communication skills and an ability to work with respect and appreciation of cultural diversity. Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams. Fluency in Spanish, English and Italian is a mandatory requirement. 2 to 5 years of experience in a similar role required. Willingness to travel. Flexible and adaptable. Why work with us? Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
For more information: www.daiichi-sankyo.es
#J-18808-Ljbffr
-
Deputy Local Safety Officer
hace 3 días
Pozuelo de Alarcón, Madrid, España Daiichi Sankyo Europe A tiempo completoJob Title: Deputy Local Safety OfficerThis role serves as the Deputy Local Safety Officer for our Spanish and Italian Affiliates, ensuring compliance with pharmacovigilance regulatory requirements globally and locally. The successful candidate will oversee the local pharmacovigilance system, executing operational tasks and acting as the Deputy of the...
-
Deputy Local Safety Officer
hace 3 días
Pozuelo de Alarcón, Madrid, España Daiichi Sankyo Europe A tiempo completoJob Title: Deputy Local Safety OfficerThis role serves as the Deputy Local Safety Officer for our Spanish and Italian Affiliates, ensuring compliance with pharmacovigilance regulatory requirements globally and locally. The successful candidate will oversee the local pharmacovigilance system, executing operational tasks and acting as the Deputy of the...
-
Deputy Local Safety Officer
hace 3 semanas
Pozuelo de Alarcón, España Daiichi Sankyo Europe A tiempo completoThis position primarily serves as Deputy Local Safety Officer (LSO) for our Spanish and Italian Affiliates and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV systems are operating appropriately by executing operational PV tasks.Act as the Deputy of the National...
-
Deputy Local Safety Officer
hace 3 semanas
Pozuelo de Alarcón, España Daiichi Sankyo Europe A tiempo completoThis position primarily serves as Deputy Local Safety Officer (LSO) for our Spanish and Italian Affiliates and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV systems are operating appropriately by executing operational PV tasks.Act as the Deputy of the National...
-
Deputy Local Safety Officer
hace 4 semanas
28223 Pozuelo de Alarcón, Madrid provincia, España Daiichi Sankyo Europe A tiempo completoThis position primarily serves as Deputy Local Safety Officer (LSO) for our Spanish and Italian Affiliates and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV systems are operating appropriately by executing operational PV tasks. Act as the Deputy of the...
-
Safety Officer
hace 2 meses
Las Palmas de Gran Canaria, España Team Recruitment Ltd A tiempo completoCompany: Team Recruitment LtdLocation: Las Palmas de Gran Canaria, Canary Islands, SpainPosition: Safety OfficerExperience Required: 1+ YearsEducation Required: High School/SecondarySkills Required: Safety Officer, Safety Training RepTeam Recruitment requires a Safety Officer to mobilise to a Client's Semi Sub in Las Palmas on the 2nd of September for an...
-
Safety Officer
hace 2 meses
Las Palmas de Gran Canaria, España Team Recruitment Ltd A tiempo completoCompany: Team Recruitment LtdLocation: Las Palmas de Gran Canaria, Canary Islands, SpainPosition: Safety OfficerExperience Required: 1+ YearsEducation Required: High School/SecondarySkills Required: Safety Officer, Safety Training RepTeam Recruitment requires a Safety Officer to mobilise to a Client's Semi Sub in Las Palmas on the 2nd of September for an...
-
Safety Officer Position
hace 4 semanas
Las Palmas de Gran Canaria, Las Palmas, España Team Recruitment Ltd A tiempo completoJob Title: Safety Officer Company: Team Recruitment Ltd Location: Canary Islands, Spain Job Type: Full-time About the Role: We are seeking a highly skilled Safety Officer to join our team at Team Recruitment Ltd. As a Safety Officer, you will be responsible for ensuring the health and safety of our clients and employees on offshore projects. Key...
-
Safety Officer Position
hace 4 semanas
Las Palmas de Gran Canaria, Las Palmas, España Team Recruitment Ltd A tiempo completoJob Title: Safety Officer Company: Team Recruitment Ltd Location: Canary Islands, Spain Job Type: Full-time About the Role: We are seeking a highly skilled Safety Officer to join our team at Team Recruitment Ltd. As a Safety Officer, you will be responsible for ensuring the health and safety of our clients and employees on offshore projects. Key...
-
Safety Officer
hace 4 semanas
Las Palmas de Gran Canaria, Canary Islands, España Team Recruitment Ltd A tiempo completoTeam Recruitment require a Safety Officer to mobilise to a Clients Semi Sub in Las Palmas on the 2nd of September for an 8 day ad hoc trip. Must hold NEBOSH and all relevant offshore certificates.
-
Safety Officer
hace 1 mes
Las Palmas de Gran Canaria, Las Palmas, España Team Recruitment Ltd A tiempo completoJob Title: Safety OfficerCompany: Team Recruitment LtdLocation: Canary Islands, SpainJob Type: Full-timeIndustry: RecruitmentJob Description:We are seeking a highly skilled Safety Officer to join our team at Team Recruitment Ltd. As a Safety Officer, you will be responsible for ensuring the safety and well-being of our clients and employees in offshore...
-
Safety Officer
hace 1 mes
Las Palmas de Gran Canaria, Las Palmas, España Team Recruitment Ltd A tiempo completoJob Title: Safety OfficerCompany: Team Recruitment LtdLocation: Canary Islands, SpainJob Type: Full-timeIndustry: RecruitmentJob Description:We are seeking a highly skilled Safety Officer to join our team at Team Recruitment Ltd. As a Safety Officer, you will be responsible for ensuring the safety and well-being of our clients and employees in offshore...
-
Biosafety Health and Environment Officer
hace 4 meses
Sant Feliu de Llobregat, España Centrient Pharmaceuticals Netherlands A tiempo completoCentrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms. We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our...
-
3Rd Officer
hace 3 días
Las Palmas de Gran Canaria, España Osm Maritime Group A tiempo completo3rd Officer (3/O) | Offshore - Seismic/Research Vessel | Las Palmas/ SPAINDeadline: 27 Nov 2024Join our team as a 3rd Officer onboard an Offshore Seismic/Research Vessel in beautiful Las Palmas, Spain. We're searching for a dedicated maritime professional eager to contribute to innovative offshore projects.1. Key Responsibilities:1. Assist with navigation...
-
Legal Responsible
hace 3 días
San Fernando de Henares, Madrid, España Rentokil Initial A tiempo completoDescripción del EmpleoEstamos buscando un/a Legal Responsible & Local Private Officer para nuestro equipo de Cobros en San Fernando de Henares.Las funciones del puesto incluyen:Adecuar, elaborar y gestionar los expedientes de deuda desde la fase pre-legal hasta la fase legal.Controlar, comunicar y gestionar los expedientes de los clientes acogidos a la ley...
-
Legal Responsible
hace 3 días
San Fernando de Henares, Madrid, España Rentokil Initial A tiempo completoDescripción del EmpleoEstamos buscando un/a Legal Responsible & Local Private Officer para nuestro equipo de Cobros en San Fernando de Henares.Las funciones del puesto incluyen:Adecuar, elaborar y gestionar los expedientes de deuda desde la fase pre-legal hasta la fase legal.Controlar, comunicar y gestionar los expedientes de los clientes acogidos a la ley...
-
Safety Supervisor
hace 4 semanas
Alcalá de Guadaira, Sevilla, España Wright Tree Service A tiempo completoSafety Supervisor **Job Summary** Wright Tree Service is committed to providing a safe and healthy work environment for all employees and applicants. We are seeking a highly skilled Safety Supervisor to join our team. **Key Responsibilities** * Ensure compliance with all relevant safety regulations and standards * Conduct regular safety audits and...
-
Safety Supervisor
hace 4 semanas
Alcalá de Guadaira, Sevilla, España Wright Tree Service A tiempo completoSafety Supervisor **Job Summary** Wright Tree Service is committed to providing a safe and healthy work environment for all employees and applicants. We are seeking a highly skilled Safety Supervisor to join our team. **Key Responsibilities** * Ensure compliance with all relevant safety regulations and standards * Conduct regular safety audits and...
-
Safety Supervisor
hace 4 meses
Alcalá de Guadaíra, España Wright Tree Service A tiempo completoTitle : Safety Supervisor Type : Full-Time/Exempt Reports to : Senior Safety Lead/Safety Manager Essential Functions : Wright Tree Service employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability...
-
Hse Trainee
hace 4 semanas
Pozuelo de Alarcón, España Flowserve A tiempo completoFlowserve is a world-leading manufacturer and aftermarket service provider of comprehensive flow control systems.Driven by our Purpose, we are committed to building a more sustainable future to make the world better for everyone.With more than 16,000 employees in more than 50 countries, we combine our global reach with local presence.We support more than...
