Uk-deputy Pharmacovigilance Cluster Lead Uk

5 months ago

Uxbridge, United Kingdom Daiichi Sankyo Europe Full time

**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

**Location**:
Hybrid - Home Based (up to 4 days a week) and Head Office
Travel across UK and Europe as required.

**Purpose**:
This position primarily serves as a deputy local safety office (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. 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**:
**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.
- Creates 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.
- 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.
- Flexible and adaptable.

**Why work with us?**:

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