Uk-deputy Pharmacovigilance Cluster Lead Uk

3 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?**:

  • Senior Pharmacovigilance

    3 months ago

    Uxbridge, United Kingdom Parexel Full time

    When our values align, there's no limit to what we can achieve.   Due to an expanding portfolio, we have an exciting opportunity for a highly skilled and experienced Senior Pharmacovigilance (PV) Compliance Manager, QA to join our team in the Czech Republic or other selected Eastern Europe countries. Candidates must have a strong knowledge and...

  • Compliance & Contracts Specialist - UK & Ireland

    2 weeks ago

    Uxbridge, United Kingdom Almirall Full time

    About Almirall Almirall is a pharmaceutical company dedicated to improving global healthcare through innovation and partnerships. We research, develop, manufacture, and market our own medicines as well as licensed products across various therapeutic areas. Our reach extends to over 70 countries on five continents. Our Values At Almirall, we are guided by...

  • Director of Pharmacovigilance and Safety Science

    7 days ago

    Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time

    Job SummaryThe Associate Director, Pharmacovigilance Scientist will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate safety messaging and...

  • Associate Director, Pharmacovigilance Scientist

    4 days ago

    Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time

    Job SummaryThe Associate Director, Pharmacovigilance Scientist will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate safety messaging and...

  • Associate Director, Pharmacovigilance Scientist

    4 days ago

    Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time

    Job SummaryThe Associate Director, Pharmacovigilance Scientist will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate safety messaging and...

  • Senior Manager Cluster Coordination and Transformation

    9 hours ago

    Uxbridge, United Kingdom Coca-Cola Europacific Partners Full time

    About the RoleWe are seeking a highly skilled Senior Manager to lead our Cluster Coordination and Transformation efforts in the Benelux region. As a key member of our Customer Service & Supply Chain team, you will be responsible for managing strategic initiatives and driving business growth across the region.Key ResponsibilitiesTransformation Program...

  • Senior Manager Cluster Coordination and Transformation

    7 hours ago

    Uxbridge, United Kingdom Coca-Cola Europacific Partners Full time

    About the RoleWe are seeking a highly skilled Senior Manager to lead our Cluster Coordination and Transformation efforts in the Benelux region. As a key member of our Customer Service & Supply Chain team, you will be responsible for managing strategic initiatives and driving business growth across the region.Key ResponsibilitiesTransformation Program...

  • Senior Manager Cluster Coordination

    5 hours ago

    Uxbridge, United Kingdom Coca-Cola Europacific Partners Full time

    Senior Manager Cluster Coordination, Pan EU Context:How would you like to be able to leave your mark on how we operate across all functions within Customer Service & Supply Chain in Belgium, Luxembourg and The Netherlands? In this position, you will focus on managing strategic initiatives across the Benelux Customer Service & Supply Chain function. This...

  • Toblerone UK Brand Strategist

    3 weeks ago

    Uxbridge, United Kingdom Mondelēz International Full time

    Shape the Future of Toblerone in the UK Mondelēz International is seeking a passionate and driven Brand Manager to lead the iconic Toblerone brand in the UK. This is a unique opportunity to contribute to a transformative journey for one of the world's most recognizable chocolate brands. As a key player in our global team, you will develop and execute a...

  • Toblerone UK Brand Manager

    3 months ago

    Uxbridge, United Kingdom Mondelēz International Full time

    Description Brand Manager Toblerone UK A unique opportunity to participate to a transformative journey on Toblerone, one of the most iconic chocolate brands in the world. We are on a pursuit to grow our premium business globally, and UK is a key success market being one of our biggest markets globally. To support our ambition, we’re creating a...

  • Civil Enforcement Officer

    3 months ago

    Uxbridge, United Kingdom APCOA PARKING (UK) LTD Full time

    **The Role**: **Civil Enforcement Officer - Hillingdon, West London -** Full Time 42 Hours per week - £25,006 per annum** **This role has an imminent salary up lift as new rates of pay are being discussed.** - Do you enjoy working outdoors? Do you like helping people? Do you have great communication skills?_ - Do you have excellent customer service skills?...

  • Toblerone UK Brand Manager

    2 days ago

    Uxbridge, United Kingdom Mondelēz International Full time

    About the RoleWe are seeking a highly skilled and experienced Brand Manager to lead the Toblerone brand in the UK market. As a key member of our team, you will be responsible for developing and executing a comprehensive brand strategy that drives premium growth and shapes the future of chocolate.Key ResponsibilitiesDevelop and implement a brand portfolio...

  • Toblerone UK Brand Manager

    2 days ago

    Uxbridge, United Kingdom Mondelēz International Full time

    About the RoleWe are seeking a highly skilled and experienced Brand Manager to lead the Toblerone brand in the UK market. As a key member of our team, you will be responsible for developing and executing a comprehensive brand strategy that drives premium growth and shapes the future of chocolate.Key ResponsibilitiesDevelop and implement a brand portfolio...

  • Market Access Strategist UK

    7 days ago

    Uxbridge, United Kingdom CHASE Full time

    Job DescriptionMarket Access Lead UKCHASE, a leading pharmaceutical company, is seeking a highly motivated and results-oriented professional to fill the role of Market Access Lead UK. As a key member of our team, you will play a vital role in ensuring optimal market access for our portfolio, driving patient access and maximizing the impact of our...

  • Senior Manager Cluster Coordination

    2 days ago

    Uxbridge, UK, UK, London, United Kingdom Coca-Cola Europacific Partners Full time

    Senior Manager Cluster Coordination, Pan EU Context:How would you like to be able to leave your mark on how we operate across all functions within Customer Service & Supply Chain in Belgium, Luxembourg and The Netherlands? In this position, you will focus on managing strategic initiatives across the Benelux Customer Service & Supply Chain function. This...

  • Lead Security Officer

    4 weeks ago

    Uxbridge, United Kingdom Samsic UK Full time

    Samsic UK is looking for a Security Supervisor to enhance our team. In this pivotal role, you will be responsible for safeguarding the premises and ensuring a secure environment for all. Your key duties will include:Upholding order and visibility throughout the propertyOverseeing entry and exit pointsAddressing alarms and monitoring for unusual...

  • Lead Security Officer

    4 weeks ago

    Uxbridge, United Kingdom Samsic UK Full time

    We are looking for a Security Supervisor to enhance our team at Samsic UK. In this pivotal role, you will be responsible for safeguarding our clients' facilities and ensuring a secure environment. Your key duties will encompass:Upholding order and visibility across the premisesOverseeing access points and monitoring trafficReacting promptly to alarms and any...

  • Head of Medical, UK

    2 months ago

    Uxbridge, United Kingdom Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Global Medical Content Lead

    7 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Job Summary:Park Street People is seeking a highly experienced Medical Information Associate Director to join our client, a leading global pharmaceutical company, in a full-time, 12-month temporary role. As a key member of the Medical Information team, you will play a pivotal role in leading the team to deliver high-quality, accurate, and impactful content...

  • Venue Operations Co-ordinator

    3 months ago

    Uxbridge, United Kingdom Encore Global Full time

    **Venue Operations Coordinator**: **Uxbridge, UK**: **_ Salary: £30-34k (dependant on experience)_** **Position Overview**: As a member of the Venue Operations Teams, the Operations Coordinator will work collaboratively to process work orders related to Labour and equipment requests of Venues, process service requests from Venues, and ensure effective...