LTO Partner - Section Lead: Safety

Employer
Roche
Location
Welwyn
Salary
Competitive
Closing date
16 Oct 2020

View more

Discipline
Clinical Research, Drug Safety
Hours
Full Time
Contract Type
Permanent
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LTO Partner - Section Lead: Safety

About Roche UK

We're here to deliver better outcomes to more patients, faster.

That means the world to us.

Our achievements help to transform the lives of millions of people. We've been supporting patients for over 100 years in the UK, building a reputation that we're intensely proud of. Through this success, we've set an incredibly high standard. Those expectations continue to grow. The environment in which we operate changes at an ever-increasing pace. The industry is never going to stand still.

As one united team at Roche UK, we know we need to boldly respond to these changes whilst keeping our customers and our patients at the heart of everything we do.

So, we're shooting for the stars, transforming ourselves into a much more open, dynamic, transparent, inclusive, collaborative and agile business.

Our Commitments

"Better outcomes to more patients, faster."

  • Healthcare partners are 'wowed' when they work with us
  • Our innovations are faster and bolder 
  • We provide services and products to better serve people
  • Purpose is our primary motivator
  • We spend our time contributing where it adds the most value

 

… we ensure brilliance across the organisation

… we can feel brave, innovate and take calculated risks within legal and ethical boundaries...not fearing consequences if things "go wrong"

… we can bring our authentic selves to work 

… We do not need permission. We take personal accountability and trust each other..

… we can develop our career based on our passion, experience & behaviour and play to our strengths

… we work within less hierarchy - and with more coaching 

… everyone can be a leader, regardless of role

… we aim to spend 20% of our time on personal development

Our UK operating model is based on the following principles:

  • Flexible resourcing across fit-for-purpose teams to address specific needs and priorities
  • Healthcare-driven focus through outcomes
  • Consultation, individual empowerment & accelerated decision-making through decentralisation
  • Customer focus through mutually beneficial partnerships
  • Collaboration
  • Transparent portfolio level prioritisation


Mindset and behaviour is as important to us as experience and capabilities.

We won't tell you how to behave with detailed competency frameworks; we ask you to bring your differences so we can celebrate a more diverse and inclusive workforce. 

We offer a starting point for you to consider and to reflect on what this might mean for you: we're building a culture that is centered around growth mindset, prioritisation, ownership and accountability.  We need individuals who are courageously authentic in their thinking and in their actions.  This is what excites us about our future. 

We believe that on-going personal transformation is the heart of on-going organisational transformation and that fundamental to this is knowing yourself. 

For us, knowing yourself means being aware of your own strengths and weaknesses, your passions and fears, your desires and dreams, your thoughts and feelings, your likes and dislikes, your tolerance and limitations. Knowing yourself requires you to: regularly stop, pause and reflect as you change and develop over time, invite and share feedback regularly and know where to focus your development, know when to hold things lightly and what to let go of. Knowing yourself means knowing your purpose and what fulfills you, it enables you to be authentic and truly bring your whole self to work.

 

LTO Partner - Section Lead: Safety

Accountable for ensuring oversight of affiliate compliance with Pharmacovigilance (PV) legislation.  Fulfils the role of Local Safety Responsible (LSR) for the UK & assigned territories of Gibraltar and Falkland Islands.  Maintains oversight of safety risk management and all other pharmacovigilance (PV) activities.  Liaises with external professional bodies to bring strategic insights and contributes to shaping the future PV requirements. Ensure appropriate prioritisation, oversight & resource allocation to meet expected regulatory requirements and to ensure compliance with global Roche and local regulatory requirements for all areas of responsibility

NB: Dotted reporting line into the global head of International Pharmacovigilance via the Country Cluster Lead.  

Experience practicing medicine with a GMC registered physician with a "License to Practice" preferred.  Significant experience in safety & pharmacovigilance (advanced level of experience) with additional experience in Clinical Research and / or Medical Affairs highly desirable.  Extensive knowledge of regulatory requirements (UK and EU).  Substantial leadership experience in Pharmaceutical or Biotech industry required.

LSR Role Description

UK and assigned territories of Gibraltar and Falkland Islands

The Local Safety Responsible (LSR)/Head of Drug Safety

• Reports to: License to Operate Lead (solid line), Global Head of IPV through the Country Cluster Leads (dotted line) 

Key Activities and Responsibilities

Key activities include but are not limited to (for detailed information, please refer to Roche PV Policy/SOPs and Affiliate PV Manual, which contains PV standards for LSR/LSU activities):

I. Management of Individual Case Safety Report (ICSR) from all relevant sources (solicited and unsolicited sources)

II. Local Signal Detection for local products (i.e., products without global product support), where applicable

III. Oversight of PV Medical Compliance Risk Management Plan Implementation
  • Contributes to development of local RMP and ensures oversight of its implementation in collaboration with relevant staff in accordance with Roche policies and procedures, global and local regulatory requirements.


IV. Safety Communication
  • Ensures that management of safety queries, other significant safety issues and, if applicable, local/global crises is performed according to global Roche and local regulatory authority requirements.
  • Acts as a point of contact for local Health Authorities and ensures communication of relevant safety information to external key stakeholders (as applicable).
  • Maintains oversight of the Direct Healthcare Professional Communication (DHPC), Dear Investigator Letter (DIL) and To Whom It May Concern Letter (TWIMCL) processes.
  • Provides QPPV office with all relevant information to allow their oversight and follow up on requests from the QPPV office as applicable
  • Keeps up to date with local regulations and acts as nominated person for PV (or local QPPV) if and as required by local regulations


V. Study and Program Oversight
  • Ensures appropriate safety reporting processes are in place at affiliate level and, if applicable, described in relevant local documents, for global and local interventional clinical trials, Non-Interventional Studies (NISs), Post Authorization Studies (PASS/PAES), Market Research and Patient Support Programs (MAPs), Pre-Approval and Post-Trial Access Programs and Compassionate Use in accordance with Roche policies and procedures, global and local regulatory requirements.


VI. Management of Aggregate Reports
  • Provides safety related information to global teams for the preparation of Aggregate Reports, where applicable.
  • Ensures preparation of Aggregate Reports for local products, where applicable, in collaboration with local Drug Regulatory Affairs.
  • Maintains oversight of submission of PSURs/PBRERs and DSURs/SSRs (as applicable) to local regulatory authorities in accordance with Roche policies and procedures, global and local regulatory requirements.


VII. PV Quality
  • Ensures collection and analysis of PV metrics and KPIs.
  • Provides input on the PV KPIs for discussion, including at formal affiliate Management Reviews.
  • Maintains oversight and provides reports to relevant stakeholders and senior management on the local PV system performance.
  • Act as SME for any affiliate PV-related CAPAs
  • Acts as the Local Process Owner for PV-related local processes and procedures.
     

VIII. Contract Review and PV Agreements
  • Reviews contracts and provides input on necessary clauses/sections/wording for ensuring PV medical compliance.
  • Reviews and approves the safety clauses/sections/wording in local commercial agreements. Ensures preparation and execution of PV Agreements, where necessary.
  • Maintains oversight of PV activities as outlined in the PVA for local commercial agreements.


IX. Labelling and PV Commitments
  • Ensures awareness of and contributes as applicable to local safety label updates.
  • Contributes to the implementation of PV commitments, when applicable.


X. PV Oversight Of Countries With No Roche Presence (where applicable)
  • Ensures oversight and tracking of PV activities in all countries under the LSR responsibility


XI. Management of the Local Safety Unit (as applicable)
  • Leads a team of motivated individuals and promotes PV standards across the local organisation
  • Ensures an adequate level of PV expertise of the LSU members, and provides training and development opportunities for the LSU members as appropriate.
  • Ensures PV activities are properly resourced and escalates issues when required. 
  • Plans proper headcount to ensure adequate resourcing and business continuity.


 

XII Monitoring and Oversight of Service Provider Management/Outsourcing process


  • Provides input for the relevant service provider Functional Oversight Responsible (FOR) to ensure that PV requirements are met 
  • Acts as a FOR for GVP service providers, as applicable.


XIII PV Approver for Market Research and Patient Support Programs (MAPs)
  • Ensures that a PV Approver for Market Research and Patient Support Programs (MAPs) is in place


If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.  In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression. 

To be considered for this position, please apply using the link below.

When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

 

 

Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety

At Roche we believe life is incredibly precious and everyday we strive to solve some of the greatest and most complex health challenges facing humanity.  We help millions of people all over the world live longer and better lives every hour of every day and we’ve been writing scientific history for over 120 years. If you really know yourself and want to be part of our international family, dedicated to making a real impact on the world around us, the next step is yours.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/roche-careers-hub/

Contact Us
  • P.O. Box 8
  • Welwyn Garden City
  • AL7 3AY
  • GB
  • +44 1707 36 6000
  • Mini-site: Roche
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