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Principal Pharmacovigilance Liaison Scientist, Case Management Group

Location:
Brentford
Company:
GlaxoSmithKline

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Job description

Site Name: Belgium-Wavre, RTP, UK - London - Brentford
Posted Date: Jun 19 2020

The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants and patients administered GSK products, by ensuring the successful collection, assessment and reporting of safety data (adverse events).

This role ensures that case processing activities align with GSK standards for processing HSI and that regulatory timelines are achieved. This is done by liaising with global stakeholders (both internal and external).

The job holder ensures relevant liaison-related oversight to the Case Management Group (CMG) Directors and drives the understanding of adverse event collection requirements across all business units.

Core Liaison Accountabilities

  • Contributes and interacts with stakeholders (i.e. the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), MAPs and clinical operations) to ensure that all documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and a product (following approval).
  • Liaises with other CMG divisions (Quality & Compliance and Alliance) to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and a product (following approval).
  • Contributes to CAPA development
  • Works across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements
  • Manages Liaison mailboxes for Spontaneous and Clinical Trial queries and responds to allocated queries in a timely manner
  • Where problems or issues are identified, escalates to Global CMG Liaison Manager
  • Generates new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes
  • Builds external relationships with key stakeholders
  • Demonstrates GSK values during interactions

Principal Liaison Accountabilities

  • Supports Scientists with enhancement of knowledge and skills with regards to Liaison activities, where required
  • Identifies training needs; prepares, coordinates and delivers training to staff within CMG and departments outside of SMG; designs, produces and maintains the CMG core curricula
  • Act as a global Case Management leader for process discussions, including queries on strategy/policy related decisions; authors or provides significant input to standard operating procedures (SOPs) and guidance documents
  • Drives implementation of new regulations and maintenance of EMA/CRO/licensing partner reporting rules; demonstrates expert working knowledge of the regulatory environment on a global level

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Essential Core Liaison skills

  • Degree in life sciences or medically related field or previous experience equating to educational requirements.
  • Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements
  • Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
  • Project management experience preferred
  • In-depth understanding of medical and drug terminology
  • Proven experience of Prioritisation and time management
  • Strong communication skills

Desirable Liaison skills and Experience

  • Health care professional (e.g. pharmacist or nurse) preferred.
  • In-depth knowledge of GSK safety database strongly preferred
  • Knowledge of GSK products

Global CMG Liaison Principal Scientist

  • Proven experience developing and delivering high-quality training
  • Experience of providing mentoring to other staff

Competencies:

Core Liaison Competencies

  • Demonstrates GSK values in behaviour and attitude to all activities
  • Demonstrates technical expertise in clinical trial safety processes, including regulatory interpretation, SOPs/guidances, and systems/database conventions
  • Possesses comprehensive operational knowledge and understanding of the drug development process and drug approval process in major countries
  • Able to prepare and effectively present data/information within and outside of the Central Safety Department (CSD)
  • Demonstrates excellent oral and written communication skills
  • Attention to detail, but demonstrates pragmatism where appropriate or high degree of accuracy and attention to detail
  • Possesses solid/excellent technical writing skills
  • Possesses solid/excellent computer skills and computer literacy (e-mail, word processing, PowerPoint, prefer experience with relational databases, i.e. ORACLE)
  • Demonstrates project management skills in a global matrix environment

Principal Liaison

  • Ability to act as a training resource for selected activities (demonstrating good presentation skills)
  • Displays a senior level of coordination ability
  • Able to coordinate challenging conversations to resolve issues in a professional manner, demonstrating GSK behaviours and recognise when escalation is required

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

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