Regional International Pharmacovigilance Leader (m/f)

REFERENZNUMMER:

323437/11

IHRE AUFGABEN:

-Ensure compliance with regulations and guidelines, escalating issues impacting global PV processes or potentially impacting other affiliates
-Represent PDS for safety activities in interfaces with regional counterparts in the RMCO and Clinical Country Operations to ensure alignment with issues impacting company PV standards
-Establish excellent working relationships with affiliates to ensure exchange of information enabling a high standard of PV knowledge within the affiliates and an in-depth understanding of what is needed to achieve the highest compliance with global PV guidelines (this includes liaising with functions that interface with the local safety unit, such as regulatory, medical affairs, quality, manufacturing and commercial personnel)
-Ensure workload drivers of the affiliates are assessed on a regular basis and provide support to have resources in place as appropriate
-Ensure that assigned countries adhere to the PV policies and procedures while new or revisions to existing local reporting requirements for the local health authorities are properly implemented
-Act as the change manager and oversee the implementation of PV processes at local level

IHRE QUALIFIKATIONEN:

-Significant PV experience in all aspects of PV
-Experience in working with health authorities
-Demonstrated experience of proactively driving a team in a variety of tasks and projects
-In-depth knowledge of PV, GVP, ICH-GCP and other relevant standards and guidelines
-Well-versed in medical and safety aspects of FDA, EMEA, and other relevant regulations
-Excellent PV operational knowledge
-Experience in regional and/or headquarter roles is desirable
-Knowledge of the risk management process is strongly preferred

WEITERE QUALIFIKATIONEN:

Drug safety manager