Vice President, Head of Speciality Clinical Safety & Pharmacovigilance, Open to flexible working
- Contract Type
An exciting opening to head the Specialty division of our global Clinical Safety & Pharmacovigilance organization, leading a large team supporting a broad section of the global GSK pharma business!
This is a global senior leadership position with a total reporting group in the range of 100 FTEs, including senior safety physicians and scientific functional leaders within the assigned Global Safety teams. You will oversee both strategic and day-to-day perspectives of safety evaluation and risk management activities, including but not limited to:
- Respiratory portfolio, both development and marketed products.
- Classic portfolio.
- Established portfolio.
- Generics portfolio.
- Safety evaluation and risk management activities for ViiV Healthcare portfolio.
The role reports to the Senior Vice President, Clinical Safety and Pharmacovigilance in the GSK Global Development organization and is also embedded as an integral part of the Specialty medical team, with a strong connection to the business.
It is a highly visible position serving on various high-profile leadership teams and governance boards, including both the Global Safety Leadership Team and Specialty R&D Leadership Team, and the enterprise-wide Global Safety Board.
This role will be based at GSK House, the company's global corporate headquarters in Brentford, London, UK.
- Contributes to and leads selected aspects of overall strategic plan for Speciality Safety.
- Sits on Specialty R&D Leadership Team.
- Delivery of leadership on safety and related issues to key customer groups involved with medical products covered by Speciality Safety. This includes but is not limited to clinical, epidemiology, biostats, medical affairs, manufacturing, in-licencing, regulatory, compliance, and legal.
- Close working relationship with Head(s) of the departments in Central Safety on cross-organisational initiatives and on transfer/overlap of medicines between teams.
- Compliance with relevant pharmacovigilance regulations.
- Demonstrate effective and dynamic leadership in highly regulated area.
- Leadership/sponsorship of safety evaluation and risk management improvement initiatives.
- Establish a pragmatic, flexible, focused approach to meeting time, cost and quality measures.
- Ability to build effective networks for Central Safety Department throughout GSK.
- Establish and monitor proactive resourcing strategy for Speciality Safety.
- Demonstration of superior problem solving and clinical judgement in complex situations.
- Ability to lead and manage significant change initiatives.
- Global point accountability for monitoring and assessment for safety (and related) topics and issues for development and marketed medicines.
- Reinforce, or establish where necessary, common principles/thresholds for concern for safety issues and ensure decisions are consistent with these principles.
- Ability to interpret and make decisions on complex safety and product quality issues including medical relevance and impact, particularly if impacting benefit risk.
- Engagement in medical governance via Global Safety Board, safety panels, and other various company governance boards and leadership teams.
- Overview of Product Incident Review Committees (PIRCs) and product recalls due to product quality issues.
Due to the universal application of safety related activities at all levels of discovery, development and life cycle management and therefore its impact on overall portfolio, sales and growth of GSK, you will:
- Work across the R&D, Commercial Strategy, and the Regulatory matrix environment.
- Work across product pipeline in development and products in the market.
- Network with leaders of other departments and maintain a suitable network outside GSK concerning safety related matters.
- Partner with Safety Heads of other therapeutic areas, QPPV as well as other senior leaders in the Central Safety Department.
- Be a member of Specialty R&D Leadership Team.
Management of global safety teams will include:
- People management, recruiting, training, development and retention of high-calibre staff.
- Compliance with internal SOPs, working practices, and external regulations.
- Proactive resource planning and allocation across groups and sites.
- Medically qualified (or equivalent) with significant experience of clinical medicine, preferably including cardiology and/or respiratory.
- 10-12 (+) years of increasing experience in the Pharmaceutical or Biotech industry working in Clinical Development, Pharmacovigilance, Drug Safety or a related field.
- Leadership skills and people management experience in a complex organizational environment.
- At least 8 years' experience in Pharmacovigilance /regulatory, particularly in the post-marketing area.
- Experience of decision making on product safety and quality issues.
- Must have an in-depth understanding of FDA, EMA and other Health Agency regulations regarding pharmacovigilance activities.
- Additional experience in Pharmaceutical Medicine (Drug Discovery, Drug Development, Medical Affairs, Medical Information) is an asset.
- Essential to be an effective team member and strong leader in a cross-functional department.
- Very strong communication and influencing skills.
- Strategic and innovative thinking.
- Strong analytical skills.
- Rigorous and well-organised.
- Proven track record in capability building in Drug Safety, Risk Management / Pharmacovigilance.
- In depth knowledge and experience of design, conduct and interpretation of clinical trials and pharmacoepidemiology studies.
- Proficient in prioritising assignments and able to adapt to rapidly changing priorities.
- Extensive experience in proactive risk management, ad hoc crisis management, monitoring of safety issues, and a solution-oriented approach to crisis issues under pressure.
- Outstanding change management capabilities.
- Pragmatism, with good clinical and pharmaceutical judgement.
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 in a culture of Innovation, Performance and Trust.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
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 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.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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, GSK may be required to capture and report expenses GSK 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 GSK's compliance to all federal and state US Transparency requirements.