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Job Details


GlaxoSmithKline (GSK)

SERM Medical Manager

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

‘Be You’ at GSK

At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a , we empower you to be yourself, share ideas and work collaboratively.

SERM Medical Manager

In this role you will be responsible for ...

Safety Governance and Risk Management activities

  • Deliver the medical safety input into product maintenance/development planning activities
  • May lead or participate in discussion at Global Safety Board for safety related findings in clinical development
  • Be the Global Safety representative (Safety Lead) on cross functional medical matrix teams and/or project teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues
  • Establish Safety Review Teams (SRTs) or co-ordinates leadership of multiple SRTs for projects and provides expert review of data and management of safety issues.
  • Escalate safety issues identified through the Safety Review Process to Global Safety Board if necessary.
  • Be accountable for ensuring that risk reduction strategies are included in relevant documents such as product information and risk management plans, as appropriate
  • Ensure prompt notification to TA Head of reviewed protocols that are identified as potential Post Authorisation Safety Studies (PASS)
  • Lead thinking in Global Safety around risk management plans and their implementation.
  • Present safety information at external meetings

Signal Detection, Evaluation and Labelling

  • Carry 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 and tools for aggregate data review, literature review and awareness of important individual case reports
  • Provide medical expertise to signal detection and evaluation for designated products in partnership with the responsible safety scientist
  • Proactively lead the assessment of safety data and discusses the results with the SERM Head/ product scientist. Effectively communicates with Medical and/or Clinical and other key stakeholders on signal evaluation outcomes and labelling recommendations
  • Lead presentations on labelling recommendations at Global Labelling Committee or Global Safety Board
  • Review and approves regulatory supporting documentation for labelling updates
  • Ensure 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
  • Develop quality Medical Assessments for product incident review committees incident and Dear Healthcare Provider (DHCP) letters

Regulatory Reports and Submissions

  • Support safety scientists in the production of periodic regulatory documents (PSURs/PBRERs, Annual Safety Reports etc.)
  • Be accountable for medical input, review and sign-off of periodic reports (e.g. PSURs/PBRERs) and renewal documentation submitted to regulatory agencies
  • Leada the SERM safety component of global regulatory submissions

Other SERM Activities

  • Drive 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.
  • Participate in due diligence activities by providing expert safety assessments and recommendations
  • Provide support to GSK Legal for product liability litigation, as appropriate
  • Be accountable for maintaining personal readiness in response to internal audit or regulatory inspection
  • May participate in, or lead cross-GSK activities such as safety advisory panels, task forces or scientific forums
  • Raise concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner; ensures quality and integrity of issues being escalated
  • Share medical/scientific aspects of signal evaluation and risk management with safety scientist
  • May deputise for the SERM Head

Why you?

  • Medical Degree (clinician/physician/medical/ General practitioner) – MBBS or equivalent. Veterinarians and Dentists may also be considered
  • 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 Global Safety 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 and post-approval product maintenance in major countries
  • Proficient in written and spoken English
  • Sound computing skills

Preferred Qualifications

  • A post graduate qualification (e.g. Master, PhD etc.) would be desirable
  • Industry experience – especially multi-function experience e.g. clinical safety + medical affairs/clinical development would be ideal

Core Competencies

  • Leadership capability – demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.
  • Strategic Thinking – maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems.
  • Business Acumen – Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D.
  • Project Management – Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.

Why GSK?

  • Career at one of the leading global healthcare companies
  • Contract of employment
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
  • Life insurance and pension plan
  • Private medical package with additional preventive healthcare services for employees and their eligible counterparts
  • Company Car or Car Allowance
  • Long term incentives
  • Sports cards (Multisport)
  • Possibilities of development within the role and company’s structure
  • Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
  • Supportive community and integration events
  • Modern office with creative rooms, fresh fruits everyday
  • Free car and bike parking, locker rooms and showers

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