Manager PV

Job description

JOB DESCRIPTION:

Pharmacovigilance Manager UA & CIS

Main responsibilities:

·  Ensures local processes and procedures for Ukraine and CIS countries are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations;
·  Maintains compliance with local agreements, including reconciliation between partner companies Compliance;
·  Acts as the key Affiliate contact for both internal audits and Regulatory Authority inspections;
·  Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Abbott Global Pharmacovigilance (GPV), and of ICSRs and Periodic Reports to the Regulatory Authority;
·  Reports monthly compliance metrics to GPV within the required timelines;
·  Maintains awareness of local PV legislation;
·  Ensures GPV is promptly notified of any changes to relevant Local Legislation;
·  Co-ordinates Affiliate review and submission of periodic safety reports;
·  Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies;
·  Ensures any changes to Affiliate safety personnel are communicated to the Regulatory Authority (if required by national legislation), GPV and the EU QPPV (if applicable) in a timely fashion.

Main requirements:

·  Higher Medical education;
·  Experience in the field of pharmacovigilance (2-3 years);
·  Excellent computer skills (PowerPoint, Excel, Word);
·  English - Upper-intermediate;
·  Driver's license;
·  Good team player, great communication skills, tolerance, pedantry, propensity to scientific work, fast learning.

JOB FAMILY:

Public Affairs-Professional Relations

DIVISION:

EPD Established Pharma

LOCATION:

Ukraine > Kiev : Karat Business Center

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable