As Pharmacovigilance Manager (PEM), has overall responsibility for the day to day management of pharmacovigilance activities for marketed products and products in clinical trials, including all Pharma products and Vaccines.

Together with CMD, NSC supports the GM oversight of Enterprise Patient Safety Risk including review at local RMCB:

• Collection of adverse events (AEs), and Follow-up actions from all sources, recording in the country register and timely reporting of HSI reports to Global Safety (GS) via Global service  Provider

• Timely reporting Human Safety Information (HSI) and Follow-up from all sources to local regulatory authorities in Ukraine and PEM; quality check of reported cases.

• Duplicate check of all reports and maintenance of a local register for all spontaneous, HSI, incident and pregnancy reports for PEM.

• Fulfilling local regulations regarding foreign ICSRs for PEM.

• Exchange of safety data with distributors and other licensing partners and maintenance of report files for local PV agreements as necessary (for PEM).

• Interactions with Regulatory authorities in PEM.

• Compliance with local regulatory reporting requirements of all types of periodic safety reports for products registered in PEM countries, updating local trackers.

• Safety Notification management - monitoring, tracking, preparation of communications to Health Authorities, collaboration with Medical team, submission to Health Authorities, proper archiving in Veeva system.

• Delivery of training of all staff and third-party company staff on HSI reporting and safety exchange requirements.

• Regular control of completeness of lists of registered products for respective countries, update of PI Portal as soon as possible, immediate informing Head of PV Hub PEM, Global Service Provider about changes in lists of products.

• To work with stakeholders across PEM to implement projects that improves operational efficiency on country level. These may include projects related to process improvement, systems implementation, standardization or harmonization.

Out of Hours:

• Ensuring a robust process is in place for the receipt of spontaneous case reports outside business hours.

• Maintaining a log of out of hours calls and check it in PEM.

Monitoring of Local Regulations (PEM):

• Forwarding an English translation of local Pharmacovigilance regulations, including any updates to the GS.

• Notifying the relevant GS and Global Regulatory Function (in conjunction with the local regulatory department) of any commitments relating to Pharmacovigilance issues.

General:

• Properly perform tasks and effectively collaborate with team members and the manager of the structural unit PEM Hub.

• To treat goods and other items of value of the Company given to her for storage or for other purposes, which are used in the course of the work process, with due care, to take measures to prevent damages.

• To undergo instructing and training as applicable.

Quality Management System (QMS):

Maintain and improve:

• QMS at local level in line with area of responsibility to ensure that local operations are in full compliance with GSK standards and policies.

• Сommunication of QMS importance to company staff.

• Support and improve QMS within the zone of responsibility at LOC level to guarantee all actions are in full compliance with global written standards and policies, Guide for commercial Companies and local SOPs.

Why you?

Qualifications:

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

• Higher medical or pharmaceutical education
• 2/3 years of experience working in the pharmaceutical industry; experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes
• Solid grounding in clinical, medical and pharmaceutical science with the ability to rapidly assimilate specific and detailed knowledge in these areas
• Experience evaluating and effectively communicating evidence-based medicine
• Strong scientific communication and presentation skills.
• Fluent English (written & oral) level
• Comprehensive user of PC applications (confident user of MS Office applications (Word, Excel, and Power Point) and literature search engines

Why GSK?

At GSK we offer a wide range of additional benefits: 

• Career at one of the leading global healthcare companies

• Hybrid work ( 2/3 days per week from the office) of fully remote

• Contract of emp