SERM Director ViiV, Open to flexible working
Who We Are: The Specialty Safety Evaluation and Risk Management (SERM) Group
Global Safety is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products, and for the ongoing safety evaluation and risk management of all GSK products (marketed or developmental). This role within GSK is specifically aligned to provide safety support and expertise to ViiV Healthcare (ViiV: www.viivhealthcare.com) which specialises in HIV treatment, prevention and care.
Are you a safety/pharmacovigilance physician or scientist with in-depth and hands-on experience in early phase drug development, proven matrix team leadership and strong communication skills?
We are seeking talented and intellectually curious individuals who wish to join us in SERM and contribute to the advanced benefit-risk management of the ViiV portfolio.
In this role, you will provide high level pharmacovigilance expertise to new and cutting-edge medicines in clinical development with a focus on early stage development (phase 1 – phase 2). You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements.
You will have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes. You will influence at all levels of the organisation using your experience, confidence and credibility, and represent the disease area or product area safety strategy at key internal ViiV meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners, as needed.
GSK and ViiV considers the patient safety of its products to be of paramount importance.
Safety Governance and Risk Management activities
- Delivers the safety input into clinical development planning activities
- Reviews and provides technical approval (as appropriate) for investigator brochures, protocols, informed consent forms, final study reports, and external data monitoring committee charters
- May lead or participate in discussion at ViiV Governance Boards for safety related findings in clinical development
- Represents Global Safety on cross functional clinical matrix teams and/or project teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues
- Is part of/leads the Safety Review Team for assigned project(s) in development and provides expert review of data and management of safety issues. Escalates safety issues identified through the Safety Review Process to the relevant ViiV stakeholders. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
- For designated products, drives pharmacovigilance and risk management planning in the clinical matrix and leads production and updating of Development Benefit-Risk Management Plans
- Presents safety information at external meetings (as required)
Signal Detection, Evaluation and Labelling
- May have overall responsibility for the conduct of signal detection and evaluation process of assigned products. Drives signal detection for assigned products using available methodologies, including aggregate data review, literature review and tools for individual case awareness. Makes recommendations to ViiV senior stakeholders for the assessment and prioritisation of safety signals
- Provides expertise to signal detection and subsequent evaluation for designated products in partnership other team members as required, including medical expertise if a physician
- Proactively leads the assessment of safety data and discusses the results with the ViiV senior stakeholders. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation recommendations
- If a physician, may provide medical sign-off for regulatory documentation
- Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data
- Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints. Supports production of quality incident Medical Assessments and Dear Investigator letters
- In consultation with team members and Clinical Development representatives prepares the Development Core Safety Information for assigned development products; including co-ordinating meetings and tracking timelines to ensure completion
Regulatory Reports and Submissions
- Drives production of periodic regulatory documents (DSURs, Annual Reports) according to the agreed process and timelines
Other SERM Activities
- Contributes to the review of the SERM component of Safety Data Exchange Agreements and escalates any deficiencies to the relevant stakeholders to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility
- Participates in due diligence activities by providing expert safety assessments and recommendations
- Participates in ViiV internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
- Provides support to ViiV Legal for product liability litigation, as appropriate
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- May participate in, or leads, cross-GSK activities such as safety advisory panels, task forces or scientific forums
- Raises concerns/issues to senior stakeholders in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated
- Trains, coaches and mentors scientists in the medical/scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
- May provide medical safety support for the US and RoW Case Management functions. Reviews and approves safety reports to investigators in partnership with the Clinical Development physician
- May provide input to, or participate in, meetings of an independent data monitoring committee (IDMC) or internal safety review committee (iSRC)
We are looking for professionals with these required skills to achieve our goals:
- Physician: Medical Degree (i.e. clinician/physician/medical practitioner) from an accredited reputable University. For all, postgraduate medical specialisation is preferred or other relevant scientific/medical post-graduate qualification(s).
- Scientist: PhD or equivalent advanced medical sciences education
- Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
- Physician: Good medical judgement and ability to make medical decisions
- In depth knowledge of clinical development process with particular reference to phase 1 and 2
- Industry experience – especially multi-function experience e.g. clinical safety + medical affairs/clinical development
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies
- Expert evaluation skills and analytical thinking
- Outstanding medical writing skills
- Sound computing skills
If you have the following characteristics, it would be a plus:
- Advanced Experience and background in HIV
- Advanced Degree Life Sciences or Pharmacovigilance
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:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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.
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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