Pharmacovigilance/ Medical Information Manager (maternity leave)

GSK is one of the world's leading science-based pharmaceutical companies with a mission to help people do more, feel better and live longer. Our goal is to be one of the most innovative, highly effective and trustworthy companies in the field of healthcare around the world. Our strategy is to provide access to the diverse, quality and essential medical products of as many people as possible in the world, through the three global areas of our business, scientific and technical know-how and talented people. Our values and expectations are the basis of everything we do and are an important part of our culture. Our key values are patient orientation, honesty, respect for people, and transparency. Our expectations are courage, responsibility, development and teamwork.

We invite you to take part in the contest for open vacancies Pharmacovigilance/ Medical Information Manager(maternity leave)

Responsibility, details: What you should to do?

• Timely management of Medical Information enquires;
• Collection of adverse events (AEs), and Follow-up actions from all sources, recording in the country register and timely reporting of AEs to global service provider:
• Timely reporting Human Safety Information (HIS) and Follow-up from all sources to local regulatory authorities in Ukraine and PEM;
• Maintenance of a local register for all spontaneous, AE, incident and pregnancy reports for PEM;
• Keeping LAM rules updated;
• Exchange of safety data with distributors and other licensing partners and oversight of new agreements with safety clauses (for PEM)
• Submission of DSURs, PSRIs to the local regulatory authorities for products registered in Performance Emerging Markets countries, maintaining local schedules and tracking them in OPAL
• Delivery of HSI training for all GSK staff and oversight of third party company staff training on HSI reporting and safety exchange requirements
• Regular control of completeness of lists of registered products for respective countries, timely  update of PI Portal, immediate informing Head of PV/MI Hub PEM, OASIS Management Team (and literature agency in CIS) about changes in lists of products
• Metrics (Ukraine and PEM):
• Responding to Operating Company metric requests from CSD for “reason for late reporting” from the OC
• Providing information as requested by CSD, in a timely manner to assist in the compilation of the quarterly pharmacovigilance report (QPV Report)
• 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 CSD
• Notifying the relevant CSD and Central Regulatory Function (in conjunction with the local regulatory department) of any commitments relating to Pharmacovigilance issues
• Quality Management System (QMS):
• Regular management monitoring of all pharmacovigilance activities across CIS, Middle East and Africa clusters.

Requirements:

• Higher education - Medical Doctor/ Pharmacist
• Preparation Direction –PV and MG
• Specific therapy area knowledge in current or near future GSK therapy area. Clinical practice in assigned therapy area. Pharmaceutical industry experience (preferred)
• Experience in clinical research (preferred) and teaching physician practice (preferred).
• Experience in clinical trials (preferred)
• 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 academic background having participated in, or led research projects and authored publications (preferred)
• 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)

We're open to all talent - whatever your gender, disability, marital status, religion or belief, age, race, sexual orientation, ethnic or national origin.