Manager, Pharmacovigilance (PV) Operations, Optimisation Brentford, England
Job description
Posted Date: Sep 12 2023
376504 Manager, Pharmacovigilance (PV) Operations, Optimisation
The key purpose of this role is to support Pharmacovigilance Operations “PV Ops” - Training, document management and Regulatory Intelligence impact in the following activities:
- Training and development of staff and vendors
- Audit and inspection coordination
- Documentation and archiving
- The development of written standards such as user guides and coding conventions and the management of regulatory intelligence.
The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.
In this role you will
-
Key Leadership Accountabilities:
- Identify training needs and work with PV OPS Optimisation colleagues to prepare, coordinate, and deliver training to staff within PV OPS and other stakeholder groups
- Act as a PV Ops leader for process discussions, including queries on strategy/policy-related decisions; authors or provides significant input into the development of written standards
- Act as a PV Ops leader for process discussions and changes, reinforcing the principal of SPADM (single point accountability decision making)
- Provide strategic direction for the coordination of audits and inspections associated with PV Ops and oversight of PV Ops CAPAs
- Provides development opportunities and capability building initiatives, providing guidance and direction to the team to achieve objectives
-
Core Technical Accountabilities:
- Contribute to creation or development of PV Ops processes and written standards
- Collaborate with stakeholders (e.g., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations/Sciences/Development) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
- Work across a complex matrix environment to ensure compliance with internal standards and external regulatory requirements
- Where process or training issues are identified, facilitate investigation into root cause, creation of corrective/preventative actions (CAPAs), and support with remediation of process/training needs
- Review and maintain oversight of PV Operations training materials
- Work with content owners and experts to prepare internal and external presentations as required
- Implement changes to PV Ops training curriculums in line with current PV Ops structure and maintain oversight of PV Ops training aspects
Closing Date for Applications: September 13th, 2023 (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.
#LI-GSK
Why you?
Qualifications & Skills:
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 requirements
- Previous experience working in Pharmacovigilance in a professional environment, ideally within a QA/CAPA framework
- Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements
- Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
- In-depth understanding of medical and drug terminology
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. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
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.
We’re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we’re excited for our move to the vicinity of Earnshaw Street, London WC1A (“the New HQ”) by end H1 2024.
