Вакансія Pharmacovigilance/ Medical Information Manager (Export Markets)

Purpose of Work Position:

- As Pharmacovigilance/Medical Information Manager (Export Markets), is responsible for the day to day management of pharmacovigilance for registered products and products in clinical trials, including all Pharma products, Vaccines and Consumer Healthcare products. This includes ensuring compliance with all local regulations and GSK global pharmacovigilance requirements.
- 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 Central Safety Department (CSD) via Argus;
- Timely reporting Human Safety Information (HIS) and Follow-up from all sources to local regulatory authorities in Export Markets; quality check of reported cases.
- Duplicate check of all reports and maintenance of a local register for all spontaneous, AE, incident and pregnancy reports for Export Markets.
- Fulfilling local regulations regarding foreign ICSRs for Export Markets
- Exchange of safety data with distributors and other licensing partners and maintenance of report files for local SDE agreements as necessary (for Export Markets).
- Submission of all kinds of periodic safety reports (PBRERs, DSURs, PSRIs, etc.) to the local regulatory authorities for products registered in Export Markets countries, maintaining local schedules and tracking them in OPAL.
- 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, immediate update of PI Portal, immediate informing Head of PV/MI Hub Export Markets, OASIS Management Team (and literature agency in CIS) about changes in lists of products.
- Regular review (i.e. monthly) of local product complaint log and med enquires log in countries in scope to ensure that all kinds of HSI are reported to CSD.

QUALIFICATION REQUIREMENTS

- Medical Doctor or Pharmacist (bachelor degree)
- 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). Strong academic background having participated in, or led research projects and authored publications (preferred). Experience in clinical trials є необхідним.
- 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).