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Posted Date: Jul 21 2023
Job Purpose:
As Pharmacovigilance Manager (Qualified Person for Pharmacovigilance / Named Safety Contact back-up):
- Has overall accountability for the day-to-day management of pharmacovigilance for marketed products and products in clinical trials, including all Pharma and Vaccines products.
- Together with CMD, supports the GM oversight of Enterprise Patient Safety Risk including review at local RMCB.
As Medical Governance Manager:
- Ensure that all clinical, promotional, and non-promotional activities of GSK Turkey are conducted according to GCP, GPMP, local laws, regulations and GSK written standards (the Code)
- Assist GSK Turkey to realize its objectives in keeping with our culture of “Doing the Right Thing”
- Lead, model and embed consistent understanding and implementation of the principles of promotional and non-promotional practices
Your Responsibilities:
- Ensure the Governance Lead will deliver and support embedding of Code of Practice
- Monitoring of local laws, regulations and guidance, assessing the impact on local structures and procedures and informing relevant internal stakeholders
- Management of local medical governance decisions and Cross Functional Team (Legal, Ethics & Compliance and Medical) activities
- Management of LOC GSK Code of practice training and implementation
- Provide Code of Practice and local regulation guidance to the medical team & all stakeholders
- Implementation of and oversight on the internal control framework, including in-process quality controls and retrospective checks (self-inspection) of conducted medical activities in accordance with Code of Practice and local regulations.
- Ensure to have a system in place for the transfer of value (ToV) submissions to the local HA and regional teams in line with local regulation and GSK standards
- Ensure the Pharmacovigilance Lead will deliver the day-to-day management of pharmacovigilance for registered products and products in clinical trials, including all Pharma and Vaccines products. This includes ensuring compliance with all local regulations and GSK global pharmacovigilance requirements
- Monitoring of local PV laws, regulations, and guidelines, assessing the impact on local structures and procedures and informing the Director of PV Advocacy in the Central Safety Department.
- Ensure expedited reporting of periodic safety reports (ie. PBRER for renewal).
- Ensure the reporting of clinical trials’ safety information to investigators and ethical committees.
- Implementation of and oversight on in-process quality controls and retrospective checks (self-inspection) of conducted PV activities.
- Ensure the PV system and roles and responsibilities are described in a local PV written standard to ensure GSK Turkey complies with local and international reporting requirements with respect to pharmacovigilance, materiovigilance, cosmetovigilance, nutrivigilance and human safety related activities in accordance with GSK standards.
- Ensure training of all operating company staff in Human Safety Information reporting requirements according to GSK policies and local regulation. Training GM and CMD (as well as any Pharmacovigilance responsible staff) about their roles and responsibilities / accountabilities.
- Facilitate PV audits and inspections, including appropriate management and follow up of corrective and preventative actions
Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- Must be a Pharmacist, Medical Doctor, or Dentist.
- Must have demonstrated strong leadership ability, especially with regard to cross-functional initiatives and inworking with local team and ‘above country’ teams.
- Experienced coordinator of different types of programmes.
- Experienced communicator across multiple levels of the organization.
- Demonstrated ability to successfully handle multiple, complex projects concurrently.
- Proven experience in the administration of different Systems.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Must be innovative
- Must consistently demonstrate a high level of indirect influencing
- Must have good attention to detail and be able to drive projects to conclusion with a high degree of autonomy
- Must have a strong cross functional awareness, good negotiation skills and be able to clearly articulate and ‘sell’ the benefits of a new process/project in order to secure the necessary buy in.
- Requires patience and flexibility of approach at various stages of the implementation of a new process.
- Robust knowledge of external environment and competitor pipelines/ portfolios and ability to use knowledge to weigh up challenges and risks to GSK; devises strategies to augment and complement the GSK future portfolio.
- Understand & identify the need of the medical team members to improve the systems and competency tools
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 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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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