Pharmacovigilance Operations Manager / Scientist

Conteúdo do emprego

Site Name: UK - London - Brentford, Home Worker - GBR

Posted Date: May 12 2022

334803 Pharmacovigilance Operations Manager / Scientist

• Please note that depending on level of experience this role will be considered at the Manager/Scientist level***
  

Are you looking for a high-profile pharmacovigilance role that ensures the accuracy of critical safety data across multiple geographies? If so, Pharmacovigilance Operations (PV Ops) Manager could be an ideal opportunity to explore.

As a PV Ops Manager, you will be responsible for aligning supplier delivery with GSK strategy, adhering to the GSK third party engagement framework, implementing third party oversight, supporting Regulatory Inspection, investigating/resolving issues and escalations from GSK LOCs and advancing methodology/process improvement initiatives. The position holder works across a matrix environment, across GSK business units, across 65 LOCs and 150 markets and outsourced providers.

The position holder will ensure that PV Ops activities provided by the suppliers align with GSK standards, that regulatory timelines are achieved, and that MI/PV standards are delivered per the outsourcing contract. The position holder will be critical to ensure the suppliers enabled to deliver the agreed upon service and meets key performance indicators. This position holder will play a key visible role to ensure that GSK regulatory and reputational risk is minimized.

In this role you will

• Work with PV Ops Directors to facilitate Vendor weekly meetings, providing information to drive continuous improvement and establish, build, and nurture relationships with vendors, LOC and internal stakeholders.
• Develop training materials to drive vendor performance.
• Develop and manage regional monitor programs for Vendor quality performance of License Partner, PMS, Spontaneous and Periodic intake and book in, SDEA annual compliance reviews, Periodic submissions, literature searches and vendor adherence to training requirements, reconciliations.
• Conduct regional trending analysis and were necessary report deviations per GSK and Vendor processes ensuring appropriate CAPA are implemented and closed out in a timely manner.
• Develop and implement effective Corrective and Preventative Actions (CAPA) for a regional HUB.
• Point of Contact for ongoing queries or issues raised from vendors, Global Safety and local operating companies.
• Implement process improvement strategies for to drive improvement, standardize the operating model.
• Conduct routine in stream and ad hoc monitoring for workflow, reporting and quality demonstrating robust sponsor oversight of service providers. Trend results and report to Regional Directors
• Liaise with global service providers to ensure focused retraining on areas of improvement occurs.
• Resolve issues/escalations reported by local operating companies
• May participate on key organization project teams such as Zero Touch processing or Process improvement/simplification activities.
• Support inspections and audits as needed.
• Conduct instream quality checks of vendor.
  

Closing Date for Applications: May 29th, 2022 (COB)

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.

Why you?

Qualifications & Skills

We are looking for professionals with these required skills to achieve our goals:

• Bachelors degree in life sciences or medically related field or previous experience equating to educational requirements
• Significant and varied professional experience in Pharmacovigilance or Medical information
• Experience working with Vendors, Safety Case Processing and Argus System knowledge
• Experience with Pharmacovigilance or Medical Information Call Center processes
• Experience in working with global service providers/vendor management
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Cultural awareness and excellent global communication skills
• Awareness of GSK local operating company governance model
• Ability to drive implementation of process improvements
• Ability to resolve issues, and conduct investigations including root cause analysis
• Experience with Spotfire dashboards
• Experience with data analytics and trending analysis
• Experience with Project management tools
  

Why GSK?

At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to , strengthen our leadership and reshape our organisation. Now, we’re getting ready to deliver the most significant change to our company in over 20 years. We’re on track to separate and create two ambitious new companies in 2022:A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health.

With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We’ll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years.

All of this depends on our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

R&D

R&D At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.

We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study starts in 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

Technology can help us find patterns in genetic data better and faster. We’re using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we’re one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.

Even with the knowledge, tools, and resources within GSK, there’s always a benefit to new perspectives. That’s why we’re increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world’s leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups.

Find out more: Our approach to R&D.

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. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

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. For more information, please visit GSK’s Transparency Reporting For the Record site.