Local Safety Officer

3 weeks ago

Uxbridge, United Kingdom Daiichi-Sankyo Europe Full time

**Passion for Innovation. Compassion for Patients.**:
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries.

**Purpose**

This position primary serves as a Local Safety Officer (LSO) for designated countries (DSUK (UK), DSIE (Ireland) 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.

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. s monitoring of local PV legislation in the country) in the designated countries. The individual will be accountable for managing other DSUK/DSIE 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 PV Cluster Lead DSUK/DSIE and is expected to work independently with specialised knowledge and use expertise to analyse and solve problems.

**Accountabilities / Measures**:
***

**Local Safety Officer at DSUK (UK)/DSIE) Ireland)**:

- Responsible for performing/overseeing all local PV activities in the designated countries.
- 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, in close cooperation with the Cluster Lead UK/IE.
- Performs/oversees monitoring of local PV legislation and implementation of Risk Management Plans (RMPs) and additional Risk Minimisation Measures as required.
- Be accountable for managing local stakeholders (e.g. Marketing) as well as local PV vendors.
- 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 and UK Pharmacovigilance System Master File (EU/UK-PSMF) by providing the up-to date information from local PV system.
- Acts as a key contributor for the affiliate audit/inspection in UK and Ireland.
- 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) and ensure periodic reconciliations are carried out.
- Oversees the activities of the PV vendor support.

**Technical/Professional Knowledge**:
***
- Previous experience of Pharmacovigilance activity in a UK affiliate, experience within Ireland 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.
- 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.
- Flexible and adaptable.

**What we offer**:

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