Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia
Posted Date: Jul 30 2021
Global Clinical Safety & Pharmacovigilance (GCSP) 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).
We are seeking talented and intellectually curious individuals who wish to join us and contribute to the development and support of novel therapies in the therapeutic areas of Oncology and Immunology. There are also opportunities to work exclusively with treatments that are in the early phases of development. GSK is not developing a pipeline of "me too" drugs, rather they are seeking to be leaders in Oncology in the areas of immune-oncology, synthetic lethality, epigenetics, and cellular & gene therapy. Additionally, GSK is leveraging its expertise in Immunology to bring forward therapies to treat COVID-19. Our portfolio ranges from first-in-human compounds to marketed drugs, so there is the opportunity to learn and contribute across life cycle management. These are exciting positions because of the patients who motivate and the science which amazes us!
Are you a safety/pharmacovigilance physician with in-depth and hands-on experience?
As the SERM Medical Director, you will provide high level medical expertise in the safety evaluation and risk management of new and cutting-edge medicines in clinical development and/or the post-marketing setting. You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives.
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 GSK meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Additionally, you will be accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs).
This role requires an experienced safety physician with proven matrix team leadership and strong communication skills.
GSK considers the clinical safety of its products to be of paramount importance.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Safety Governance and Risk Management activities
- Delivers the clinical safety input into clinical development planning activities
- Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS
- May lead or participate in discussion at Global Safety Board for safety related findings in clinical development.
- GCSP representative on cross functional clinical matrix teams and/or project teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues
- Establishes Safety Review Teams (SRTs) or co-ordinates leadership of multiple SRTs for projects in development and provides expert review of data and management of safety issues. Escalates safety issues identified through the Safety Review Process to Global Safety Board if necessary, via the TA Head. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
- Provides medical expertise for risk evaluation and risk management planning
- Leads thinking in GCSP around risk management plans and their implementation. For designated products, drives Pharmacovigilance and Risk Management Planning in the clinical matrix and leads production of Global Benefit-Risk Management Plans
- Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
- Presents safety information at clinical investigator and commercial meetings.
Signal Detection, Evaluation and Labelling
- May have overall responsibility for the signal detection and evaluation process of certain products within the SERM team, as delegated by the SERM Head. Drives signal detection for assigned products using available methodologies, including On-Line Signal Management Tool, literature review and tools for individual case awareness. Makes recommendations to SERM Head for the assessment and prioritisation of safety signals within therapeutic area
- Provides medical expertise to signal detection and subsequent evaluation for designated products in partnership with the responsible safety scientist
- Proactively leads the assessment of safety data and discusses the results with the SERM Head/ product scientist. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
- Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board
- Produces regulatory supporting documentation for labelling updates
- Provides medical sign-off for regulatory documentation and represents GCSP as the medical member of labelling discussions
- Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet
- 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
- In consultation with the product scientist and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion
Regulatory Reports and Submissions
- Drives production of periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines. Acts as technical consultant on PSURs for key assets, overseeing strategy. May review PSURs, as delegated by SERM Head.
- Supports the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market
- Accountable for medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal documentation submitted to regulatory agencies
- Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
Other SERM Activities
- Drives the review or production of the SERM component of Safety Data Exchange Agreements and escalates any deficiencies to the SERM Head 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 GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
- Provides support to GSK Legal for product liability litigation, as appropriate
Why you?Basic Qualifications:
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- Leads a complex process improvement initiative within GCSP.
- Participates in a broader, cross-functional process team within GSK.
- May participate in, or leads, cross-GSK activities such as safety advisory panels, task forces or scientific forums
- Raises concerns/ issues (i.e. sentinel events) to senior management 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 deputise for the SERM Head. May additionally deputise for the SERM Head in the Medicines Development matrix on medical issues.
- 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 GSK internal safety review committee (iSRC).
We are looking for professionals with these required skills to achieve our goals:
- Medical Degree, specialisation preferred (Board Certified or Eligible, GMC)
- Experience and background in one or more of the following areas; immunology, rheumatology, internal medicine, anti-infectives, infectious diseases, pulmonary medicine
- Submission experience - EUA, sBLA or similar
- Industry experience - especially multi-function experience e.g. clinical safety + medical affairs/clinical development Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education. Likely to be recognised as an authority in this area at high levels within GSK outside of GCSP and possibly in the external international pharmacovigilance arena.
- Expert evaluation skills and analytical thinking
- In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilisation and safety at the population level
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
- Good medical judgement and ability to make medical decisions
- In depth knowledge of clinical development process
- In depth understanding of drug approval process in major countries
- Outstanding medical writing skills
- Sound computing skills
If you have the following characteristics, it would be a plus:
- Prior experience in Oncology drug development
- Prior experience contributing to NDAs, BLAs, sNDA, and/or MAAs
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.
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