Consumer Safety Science Scientist
7 days ago
Job Purpose
- Ensure that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements.
- Perform signal detection activities to identify, assess and escalate signals appropriately, for designated products.
- Provide, with some support, product safety input on cross-functional teams.
- Support central labelling team in maintenance of product information for assigned products.
Key Responsibilities
- Perform signal detection for assigned products using available methodologies (e.g. signal management tool, literature review, individual case awareness tool), with some level of support from more senior personnel, as necessary.
- Use appropriate sources of information and database searches to retrieve relevant data for exploration / evaluation of safety signals. Communicate, escalate and document outcomes of signal detection process.
- Produce accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data with some level of support from more senior personnel, as necessary.
- May author the safety contribution to regulatory submissions for new products, formulations or indications, or support license renewal documentation, with strategic guidance from more senior personnel.
- With guidance, provide safety input into development programs involving all product types, including clinical studies, real-word evidence, post-authorisation safety studies, pharmaco-epidemiological studies, sensory studies and associated documentation.
- Assist in implementation of risk minimisation strategies in relevant documents such as umbrella branding assessments and product labelling, with guidance from more senior personnel.
- Assist in producing regulatory supporting documentation for labelling updates.
- May assist in production of safety component of Safety Data Exchange Agreements.
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
- With guidance, represent Consumer Safety Science on cross-functional project teams and contribute to process improvement initiative within Consumer Safety.
Qualification:
Degree in Biomedical or Healthcare-related specialty
Knowledge & Experience Required:
- 10+ years of experience
- Basic knowledge in causality assessment and methodologies applicable to safety evaluation & risk management activities
- Basic knowledge of the assigned therapeutic area and related disciplines (e.g. statistics)
- Basic knowledge of relevant regulations for all product types
- Sound knowledge of medical and drug terminology
- Competent medical writing skills
- Sound computing skills
- Uses range of sources and methods to gather information, identifies and proposes potential solutions for addressing
- issues and makes decisions with consultation.
- Builds effective working relationships and responds to needs of stakeholders in relation to safety issues.
- Takes account, with guidance, of the internal and external environment when considering safety issues
Why Haleon?
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 Haleon 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
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. 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.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s compliance to all federal and state US Transparency requirements.
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