Patient Safety Lead

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **Patient Safety Lead** in Madrid, Spain. **Here, you will be a vital contributor to our inspiring, bold mission.**

**JOB FUNCTION**:

- Under the leadership of the Southern Europe Pharmacovigilance Manager to set up and maintain an efficient local pharmacovigilance (PV) system in compliance with the national regulations for Human medicinal products and with Takeda Pharmacovigilance procedures for the countries under the Southern Europe cluster scope.
- To be the local contact person deputy for the Competent Authorities (CA) in Spain regarding any pharmacovigilance topics and to provide the CAs with information concerning benefit and risk balance of medicinal products in close cooperation with GPSE and the EUQPPV and, where appropriate, with other stakeholders in a timely manner, if required.
- To support appropriate contacts with relevant internal local interfaces in Spain, such as Regulatory Affairs, Quality Assurance, Commercial, Legal and Medical Department.
- To answer any pharmacovigilance related inquiries from external customers, such as health care providers or patients.
- To support the EUQPPV and cooperate with other local and EMEA / Global interfaces in the management of drug-related product issues and the coordination of PV-related activities.
- To immediately notify EUQPPV and GPSE of any potential safety concerns including potential disruption of the PV-system and measures taken, followed by regular updates on the
- resolution.

**ACCOUNTABILITIES**:

- Establishes and maintains a local PV system in accordance with local legislation and Takeda requirements
- Manages safety information in Takeda local PV unit (LOC) according to appropriate Standards and SOPs.
- Works in collaboration with Global Pharmacovigilance (GPSE) to prepare and maintain Pharmacovigilance Service Level Agreements and PV Agreements for the territory.
- Supervise safety reporting and other pharmacovigilance activities for licensed products to meet global regulatory/safety requirements
- Keeps abreast of local PV legislation and notifies GPSE of any changes
- Informs GPSE on all local 3rd party agreements (e.g. in-licensing or out-licensing of products)
- Monitors local Risk Management Plans (RMP) and risk minimization activities relevant for the territory.
- Monitors Market Research (MR) and/or Patient Support Programs (PSPs) conducted at the LOC to ensure safety information is managed appropriately
- Where appropriate / applicable to review protocols for local studies and to define PV related processes for local / area study projects prior to their initiation, in order to ensure compliance with the pharmacovigilance requirements and company standards
- Works with Global Pharmacovigilance (GPSE) to implement any strategies related to EU and local/regional Qualified Person for Pharmacovigilance (QPPV) requirements
- rovide the EU QPPV with all relevant information to allow their oversight and follow up on requests from the EU QPPV office as applicable.
- Provide expert functional advice and assistance to other functions as needed
- Collaborates with, and provides pharmacovigilance guidance and support for inter-departmental and/or corporate initiatives
- Facilitates and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs
- Ensures PV audit/ inspection readiness at the LOC and participates as appropriate in PV audits and inspections
- Conducts PV training of all local PV employees, non-PV staff, all sites within the territory and external service providers where a PV task has been subcontracted ( If applicable)
- Set in place systems for internal compliance checks on pharmacovigilance processes
- Provides Regional Hub with monthly compliance information
- Interact with Global PV colleagues as required ensuring compliance to both local and global standards and procedures.
- Ensures local PV records and files updated in accordance with company procedures and local requirements
- Ensures 24/7 coverage for PV related matters in the LOC
- Ensuring cover for this role in times of absence
- Ensuring appropriate cover during non-working days
- Prepares, maintains and tests a Business Continuity Plan (BCP) for PV
- Notify GPSE about any changes in local PV staff

**EDUCATION, EXPERIENCE, SKILLS, KNOWLEDGE**

**Education**:

- The function requires a relevant degree in Life Sciences
- Professional experience of 2-4 years in Pharmacovigilance
- Practical PV experience from several countries within a PV System is desirable.
- Additional knowledge or skills gained through a combination of academic study, job experience is required
- Ability to communicate efficiently and timely orally and in writing in local language and in English.
- Skills in priority setting.
- Ability to liaise with the different functions at local/regional and global level e.g. GM, Quali