GlaxoSmithKline
Location
Brentford, Greater London | United Kingdom
Job description
Site Name: UK - London - Brentford, Belgium-Wavre, Warsaw
Posted Date: Mar 6 2024
Our SERM Safety Physician provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
Our safety group ensures scientifically sound review and interpretation of data and management of safety issues and escalates benefit-risk issues identified through the safety review process to safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.
With an expanding portfolio, in both development and established products, we are looking for a number of Physicians to engage in a multi therapeutic setting, including Neuroscience, Infectious Disease, HIV and more.
Key Responsibilities
Scientific/Medical Knowledge PV Expertise
Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
Leads the safety component of global regulatory submissions.
Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
Explores positions and alternatives to reach mutually beneficial agreements and solutions.
Cross-functional Matrix team leadership
Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.
Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs.
Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.
Leads inspection readiness and prepared as needed to support audits/inspections.
Excellent communication (verbal, written) and influencing (internally and externally) skills.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
*LI-GSK
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
Medical Doctor (physician) (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
Experience working in large matrix organizations
Advanced experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
An understanding of both clinical trial safety and post marketing.
Experience of working with oncology patients.
GMC registered or local equivalent
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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 neurodiversity, 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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .
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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