Pharmacovigilance Lead

The Pharmacovigilance Lead has overall responsibility for the day-to-day management of pharmacovigilance for marketed products and investigational products in the scope of Turkey territory. Together with the Country Medical Director (CMD), the Pharmacovigilance Lead supports the General Manager (GM) to have oversight of Enterprise Patient Safety Risk, including review at local risk boards.

Key Responsibilities:

As the Local Qualified Person for Pharmacovigilance and Named Safety Contact, the Pharmacovigilance Lead has the following responsibilities:

• Overall responsibility for the day-to-day management of pharmacovigilance for marketed and investigational products in the scope of the country. This includes ensuring compliance with all local regulations and GSK global safety requirements.
• Acts as primary contact for the local Health Authority (LQPPV) and for PV Group of Association of Research-Based Pharmaceutical Companies (AIFD) in Turkey.
• Monitor local PV laws, regulations, and guidelines, assess the impact on local structures and procedures, and inform the Global Safety Department.
• Ensures the implementation of the national Pharmacovigilance System Master File (PSMF) and keeps national PSMF up-to-date.
• Ensures the implementation and submission of safety aggregate reports (PBRERs), risk management plans, additional risk minimisation measures, Dear Healthcare Professionals Letters, signal detection and management documents to local Health Authority.
• Ensures the oversight of safety vendor activities (local case management processes, local literature screening, etc.) on the local level.
• Ensures the reporting of safety information (expedited SUSARs and DSURs) to Ethical Committees if necessary.
• Implementation of and oversight of in-process quality controls and retrospective checks (self-inspection) of conducted PV activities.
• Ensures that the local PV system and roles and responsibilities are described in an up-to-date local PV written standard which complies with local regulations and global GSK procedures.
• Ensure training of all local operating company staff in Human Safety Information reporting requirements according to GSK policies and local regulations. Ensures training of GM, CMD, and NSC back-ups about their roles, responsibilities, and accountabilities.
• Ensures PV Agreements or relevant safety clauses are in place where necessary.
• 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 graduate of medical school or a pharmacist.
• Must have at least two years of documented experience working in a pharmacovigilance role
• Must be fluent in English.
• Must have demonstrated strong leadership ability, especially with regard to cross-functional initiatives and in working with local teams 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.
• Proven planning and organizational skills, as well as the ability to multi-task and problem-solve.
• Team-oriented, flexible approach.
• Must have good attention to detail and be able to drive projects to conclusion with a high degree of autonomy.
• Requires patience and flexibility of approach at various stages of the implementation of a new process.
• Self-motivated; works as part of a highly matrixed global team.

Job Posting End Date:

12.03.2024

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.

Contact information:

You may apply for this position online by selecting the Apply now button.

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