Associate Director, Pharmacovigilance Operations

As a Pharmacovigilance Operations Associate Director, you will provide input to the management of the regional PV Operations Group, and input in and leadership of PV projects. You will contribute and oversee quality and compliance of PV Operations in that region, as well as for regional people, process and technology support of PV Operations objectives. You will act on behalf of the PV organization and Parexel for all aspects of PV. You will also participate in providing high-caliber PV consulting to internal and external stakeholders and client.

Key Accountabilities: Input into the alignment of the Regional PV Operations group with the global PV organization Responsible for quality and compliance of regional PV operations group Input and oversight of Regional PV Operations processes and procedures, including continues improvement Supports the regional strategic direction and resource allocations jointly with the regional Head of Medical Services and other Senior Directors Supports market and business development on behalf of the entire PV organization Provides regional input into PV business plan, development, budget, general and growth strategy, including global expansion Acts as technical expert of PV for internal and external stakeholders Public representation on the PV organization, including attendance and presentations at international conferences as appropriate Works closely with colleagues in Medical Services Business Operations and regional Medical Operations Leaders on PV proposals and projects Supports regional Medical Monitors as required QualificationsSkills and Experience required for the role: Degree in Life Sciences Significant experience in PV or related clinical, medical and/or scientific areas Excellent knowledge of ICH, CIOMS and drug safety regulations in own region. Working knowledge of PV regulations in all other regions would be an advantage Knowledge of pharmaceutical and biotechnological world markets Senior management skills Good general business/operational skills Good influencing and negotiating skills Excellent communicator