Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director

Job description

Site Name: UK - London - Brentford, Belgium-Rixensart, Belgium-Wavre, Warsaw
Posted Date: Feb 20 2024
Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director

Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business.

Exciting opportunities to make a significant impact on patients' lives

Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.

Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.

Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.

If you are passionate about working with colleagues with world-class scientific expertise focused on delivering medicines and devices of significant value for patients and public health, we have Pharmacovigilance Scientist opportunities in the Specialty SERM Group:

• Bringing together more than 300 products, including best in class, first in class, growth and pipeline assets, our pharmacovigilance Specialty/General Medicines portfolio represents an incredible opportunity to impact the lives of 700+ million patients in the next 10 years. Many of the GSK heritage brands we manage are the leader in their therapy area or even the number one pharmaceutical brand on the market. We provide pharmacovigilance and comprehensive benefit-risk management for advanced Respiratory medicines and devices, Allergy/immunoinflammatory and Dermatology, Neurosciences, Anti-infectives including anti-microbials, antivirals (ViiV Healthcare) and antimalarials, Urology, CV/Metabolic, Hepatology and many more! Product support ranges from R&D into Post-approval, Established & Generics.
  

We have exciting opportunities for you to join our team and be motivated by colleagues, engaged and energized by the science and inspired by the patients whose needs we strive to meet.

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.
  
• Leads cross-functional process improvement team within GSK.
  
• 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.
  

As a SERM Scientific Associate Director/ Director/ Senior Director you will have the following attributes:

• Relevant Degree qualification. Higher level of education/qualification in life science discipline or relevant experience.
  
• Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety, Medical Affairs, or a related field.
  
• 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.
  
• Cross-functional Matrix team leadership in large organizations.
  
• Appropriate behavioural competencies.
  
• Strong: Leadership Capability, Strategic Thinking, Business Acumen, Project Management, Communication Skills.
  
• Ability to work across global sites.
  

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.

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