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Pharmacovigilance Operations Manager / Scientist

Research Triangle Park, North Carolina
Closing date
Oct 1, 2022

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Physical Sciences, Chemistry
Job Type
Manager, Staff Scientist
Organization Type
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***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.

Why you?

Basic Qualifications:

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 organization. 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.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

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