HireDiversity

Horsham, PA, US

Sr. Director International Pharmacovigilance-8793130116

Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Director International Pharmacovigilance. This position is based in Horsham, PA.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Global Medical Organization (GMO) is a Johnson & Johnson strategic asset that protects patients and the company, serves as role model for effectiveness, and adds real value to the R&D portfolio via

an end-to-end partnership with J&J's Therapeutic Areas.

The Sr. Director International Pharmacovigilance (IPV) is a key safety leader in charge of a critical network with J&J's comprehensive safety structure and will focus to establish alignment of GMO and the Local Safety Officers (LSOs).

The Sr. Director IPV will assess continuously the needs of J&Js international PV organization to complement the LSO model. The Group Lead will recommend and take leadership for implementing and maintaining the optimal structural model including GMO and LSOs. The incumbent will be responsible for driving alignment between GMO and J&J's global network of LSOs to ensure that International PV activities are compliant, effective and aligned with GMS's strategy.

The Sr. Director IPV will have extensive working experience with LSOs and a comprehensive understanding of global PV regulations. The incumbent will be highly effective and pragmatic change agent, able to influence all levels of senior management world-wide through technical and leadership credibility.

Additional responsibiliites of the Sr. Director, IPV include the following: Assess continuously J&J's international PV requirements through engagement with the appropriate senior managers in GMO, with GMS's key stakeholders and with Operating Companies worldwide. Develop near term plans for the alignment of GMO and the LSOs, and work with diverse stakeholders to gain support; implement and monitor the effectiveness of the plans through appropriate business and compliance metrics. Develop a proposal for the best longer term International PV operating models, including GMO and LSOs, taking into account the needs of various stakeholders. Gain stakeholder support, implement and monitor the effectiveness of the model through appropriate business and compliance metrics. Review and adjust the model as needed to maintain compliant and efficient operations. Represent the needs of the LSOs and J&J International PV network to GMO and other key governance bodies within J&J.

Qualifications


Masters degree in a relevant science subject is required. 10 years industry experience required with a minimum of 3-5 years of hands-on experience as an LSO or working directly and day to day with LSOs. Successful track record of playing a lead role in one of more major international change initiatives (e.g., lead consultant for major change initiatives or project supervisor for change programs). Excellent written and verbal communication skills. Demonstrated ability to sell contentious change proposals to senior managers.

Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Science