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PV Operations Associate Director

Collegeville, Pennsylvania; King of Prussia, Pennsylvania
Closing date
Oct 11, 2022

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Health Sciences, Medicine
Job Type
Organization Type
All Industry, Pharma
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Are you looking for a pharmacovigilance role that allows you to build industry-leading medical capabilities and accelerate promotional and scientific engagement? If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.

The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants, patients, and consumers administered or using GSK products, by supporting the successful collection, processing, and reporting of safety data of GSK products globally.

This role ensures that pharmacovigilance (PV) operational activities align with GSK standards for processing human safety information (HSI) and that regulatory requirements, including timelines are achieved. This is done by driving the implementation of robust processes and training for successful performance of PV activities, including PV vendor oversight mechanisms.

The job holder provides relevant oversight to the PV Operations (PV Ops) Directors and drives the understanding of PV requirements across all business units.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Provides project management and case processing oversight for clinical trials and post-marketed programs, supports spontaneous case processing activities; ensures timely completion of deliverables
  • Provides support and guidance to the PV Ops Study Leads and team members to ensure compliance with global regulations and adherence to GSK SOPs
  • Maintains knowledge of global regulations in relation to PV Operations activities, identifies changes to regulations that may impact PV Ops activities, assesses impact, coordinates implementation of changes and performs management monitoring, as needed
  • Manages team to ensure appropriate prioritization and time management, in line with business needs
  • Builds external relationships with key stakeholders and senior leaders
  • Resolves issues and concerns within the PV Operations steam and escalates as appropriate, where resolution is not possible or there is potential further impact
  • Generates new ideas and proposals for global implementation; identifies process gaps/areas for process improvement, develops and implements solutions, contributes to advancement of PV Ops methodology and optimization of processes
  • Ensures that all PV Operations activities are appropriately resourced and escalates any resourcing issues
  • Provides workload forecasts and works with Director to strategically plan resource and project needs, in line with business goals
  • Develops the team, identifying training requirements and establish a training plan for individuals, as required Provide strategic advice to the function or oversight of direct and/or indirect reports who perform PV activities).
  • Takes on increasing responsibility and accountability to support business needs and/or PV Operations Leadership Team
  • Leadership: Sets direction for the team so they understand how their work supports the team's goals and the organizational priorities and applies sound judgment to all that they do.
  • Decision Making: Makes well thought-out yet efficient decisions based on pertinent facts, relevant information, and good judgment. Identifies key issues, analyses cause-effect relationships, clarifies input from different sources, and reaches appropriate decisions in a timely manner.
  • Embracing Change/Innovation: Questions the status quo. Generates new ideas. Recognises the need for new or modified approaches and brings perspectives and approaches together, combining them in creative ways.
  • Teamwork: Works effectively with others to achieve business goals and objectives. Bridges personal, business and cultural differences to work effectively in team settings.
  • Business Orientation: Understanding of the operational challenges of safety stakeholders and other customers. Recognises issues and initiatives important to the business in order to facilitate development of business benefits cases and effective prioritization or process improvements in order to move the business forward. Coordinates with partners regarding new strategies to ensure consistent communication strategies. Implements processes that foster a cross-organisational approach to achieving the mission and strategic goals.
  • Customer Focus: Understands their (internal and external) customer's business. Understands customers' needs and works with them to help solve their problems. Acts quickly to respond to customers' needs.
  • Communication: Listens to others actively attends to and conveys understanding of the comments and questions of others; listens well in a group. Speaks effectively: speaks clearly and expresses self well in groups and in one-to-one conversations. Writing skills: conveys information clearly and effectively through both formal and information documents; reviews and edits written work constructively. Delivers presentations effectively: prepares and delivers clear, smooth presentations; carries self well in front of a group. Strong influencing and negotiation skills.
  • Coaching: Educated in Coaching Model and coaches individuals in many situations as opportunities arise. Seeks opportunities to take on the role of coach for others. Provides feedback routinely and demonstrates effective coaching skills in a way that preserves self-esteem and encourages success for an individual and within the organisation.

Why you?

Basic Qualifications:

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

  • Degree in life sciences or medically related field or previous experience equating to educational/practical requirements
  • Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), Clinical Trial Directive (CTD)/Regulation (CTR) reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements
  • In-depth understanding of medical and drug terminology
  • Proven experience of prioritisation and time management
  • Strong written skills
  • Solution-driven and proactive way of working
  • Proven experience developing and delivering high-quality training and coaching others
  • Proven experience in line management and navigating difficult scenarios to ensure success of the team

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Able to effectively decide when escalation mechanisms are necessary and suggest / recommend a solution, based on a combination of facts, experience and PV knowledge
  • Expert in the implementation of effective change management across a complex matrix environment
  • Strong verbal communication skills
  • Knowledge of GSK products and business structure
  • Project management experience
  • Ability to map processes and author written standards
  • Knowledge and experience with pharmacovigilance systems

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.​

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.​

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.​


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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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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.
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