Pharmacovigilance Compliance Manager - Europe remote
Accellacare
Bucharest
3 zile în urmă

The role :

Working as part of our global Pharmacovigilance and ICON Strategic Solutions, you take responsibility for managing the compliance team and the activities contracted by our clients and across our business unit to help drive our strategic vision for continual improvement and compliant deliverables.

Key responsibilities include (but are not limited to) :

Provide compliance support to our department, including the review of quality events, CAPAs

Audits / inspection prep and follow up

Provide ad hoc support to business unit team members with compliance queries or questions

Support and champion our initiative for improving our compliance culture within PVS (Pharmacovigilance & Patient Safety)

Provide direct support to client project teams where there are significant compliance issues

  • Plans, organizes and manages performance of individuals and teams; delegates effectively, leveraging team members relative strengths;
  • provides timely recognition and coaching; develops others

    Demonstrate the ability to critically assess and address the need for addition of new service lines into the SOW (scope of work)

    Work closely with the Project Manager and Director of Project Delivery and report any shortcomings and difficulties encountered to strategies towards solutions

    Support all activities related to project compliance revenue, including assessing forecasted units against actual units to support planning of resources

    Proactively engage and communicate with clients to understand their needs ensuring client satisfaction and driving increased value for them, whilst taking the organisation's costs and benefits into account

    We want our employees to prosper and ensure that they are set up for this success through constant training, development and support.

    To enable success in this position, you will be confident, methodical and able to manage your time.

    You bring :

    Previous experience in Pharmacovigilance

    Previous experience in line management (large global PV teams)

    Previous experience in a compliance environment, preferably within Pharmacovigilance e.g. :

    Trend analysis

    Working across global teams and time zones.

    Strong communication skills, both verbal and written

    Confident at presenting to stakeholders

    A common-sense and methodical approach to your work

    This is a remote-based role for maternity cover with a fixed-term contract for 24 months.

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