Local Safety Officer

hace 3 semanas

Madrid, España Daiichi-Sankyo Europe A tiempo completo

**Passion for Innovation. Compassion for Patients.**:
Daiichi Sankyo y sus 16.000 empleados en más de 20 países se dedican a la creación y suministro de productos farmacéuticos innovadores. En Europa, nos centramos en dos áreas: Cardiovascular, con una sólida cartera de medicamentos, que refleja nuestro compromiso y demuestra que cuidamos de cada latido del corazón; Oncología, cuyo objetivo es ser una compañía farmacéutica innovadora en 2025, proporcionando nuevas terapias a pacientes de todo el mundo. Nuestra sede europea está en Munich, Alemania, y tenemos filiales en 13 países europeos.

**Purpose of the function**:
This position primary serves as a Local Safety Officer (LSO) for designated country (Spain) and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensures the local PV system is operating appropriately by executing operational PV tasks.

Act as the local National Contact PV Person in Spain.

This position is accountable for ensuring proper handling of safety reporting from local to global as well as all other local PV activities (e.g. screening of local literature and monitoring of local PV legislation in the country) in the designated country. The individual will be accountable for managing other DSES stakeholders (e.g. Marketing, Medical Affairs) 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.

This position will report to the DSE PV Partner & Affiliate Manager and is expected to work independently with mínimal guidance with specialized knowledge, and use expertise to analyse and solve problems.

**Roles and Responsibilities**:
Local Safety Officer DSES:

- Responsible for performing/overseeing all local PV activities in the designated country.
- Ensures safety reports collection process in the designated countries is implemented and oversees the processes are working properly.
- Evaluates and updates local SOPs and local appendices to DSE affiliate core SOPs as required.
- Contact person for pharmacists, physicians and consumers for the reporting of adverse drug reactions (ADRs) and 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 local level as required.
- Be accountable for managing local stakeholders (e.g. 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 EU Pharmacovigilance System Master File (PSMF) by providing the up-to date information from local PV system.
- Contributes to the company’s benefit-risk evaluation for national products and to answering requests from Competent Authorities.
- Acts as a primary contact person for the affiliate audit/inspection in Spain.
- Facilitates the local implementation of global processes as required.

PV process enhancement:

- Contributes to the enhancement of EU affiliates PV Quality Management System standards by providing the inputs from local PV system.
- 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:

- Coordinate 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)
- Oversees the activites of the PV vendor support

**Qualification and Experiences**:

- University Degree in Life Science;
- Experience: 3-5 years of PV experience with an advanced degree; 8 years of experience with a bachelor’s degree.

**Skills and additional Requirements**:

- Bachelor’s degree at minimum required

(Experience as local safety officer is preferred.)
- Master degree in Life Sciences, Pharmacy or Medical Sciences preferred.
- Possesses strong knowledge of International, European and PV laws and guidance
- Good or excellent written and verbal communication skills in English
- Highly reliable with accurate operating principles
- Analytic and systematic approach with good problem solving skills
- Ability to understand complex matters with a continuous focus on improvement
- Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity
- Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams
- Flexible and adaptable

**Trabajar en Daiichi Sankyo**:
En Daiichi Sankyo, ofrecemos un lugar de trabajo donde serás escuchado. Todo lo que hacemos, lo hacemos con un alto nível de compromiso

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