Director

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.Represent GPE in the Global Device Surveillance group
Responsible for handling safety issues involving devices.
Responsible for establishing policies and procedures for device handling to allow timely recognition of potential or real safety issues.
Review all potential incident/near incident reports and make a reportability decision by utilizing the decision matrix. A discussion with Global Device Surveillance group should be initiated and the Global Safety Officer should be involved as needed. Ensure that documentation of these decisions is maintained.
Ensure timely distribution of incident/near incident cases to Device Reporting Officers/ASOs
Review aggregate device adverse events and PTCs on a monthly basis and provide an ongoing risk assessment to the Global Device Surveillance group , GSO and GPE management. This information should be available for inclusion in PSURs as needed.
Ensure system capability to capture key data to allow aggregate review of AE and PTC data.
Provide input to Device Surveillance group concerning device improvements, as well as improvements to the Quality System or Quality Manual
Support ASO training activities
Supervision of regional Device Reporting OfficersAccountabilities:1.Interface with QO sites to ensure that PTC evaluations are appropriately triaged and evaluated
2.Accountable to Global Device Surveillance group, Global Safety Officer and GPE management to ensure timely notification of potential safety issues.
3.Accountable for working with GPE and IO technical groups to ensure that appropriate system interfaces and functionality is available to support device surveillance activities.
4.Accountable to GPE management, IO management and GRAMS QA with respect to timeliness/compliance with global regulatory reporting requirements.Authorities:1.Ensure that robust systems and processes are in place to support device safety surveillance activities
2.Establish strong working relationships with the IO groups that are responsible for handling device complaints
3.Work with the Global Device Surveillance group to ensure appropriate training of ASOs in handling device complaints
REQUIREMENTS
1.Advanced degree in medical sciences (e.g. medicine, pharmacy or nursing)
2.Five years practical clinical experience
3.Three years experience in pharmaceutical industry
4.Strong writing and computer skills
5.Excellent communication and analytical skills as well as a high level of self-motivation, initiative and attention to detail are required
6.Ability to work independently and as a team player, to work on multiple projects under pressure and with tight timelines