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Medical Sciences Opportunities at Parexel

Medical Sciences

Director / Senior Director Pharmacovigilance (PV) Operations

Job ID 61023BR USA - Any Region - Home Based
Incredible opportunity to bring your PV Leadership experience to Parexel!

In this highly visible leadership role, you will work with top pharmaceutical companies and emerging biotech clients to help bring their strategies forward and make incredible impacts on the lives of patients. You will use your PV expertise to serve as a trusted partner to clients and draw upon your leadership talent to inspire and motivate our highly experienced North American team. All while gaining tremendous exposure to a variety of therapeutic areas and interesting compounds.

The Director / Senior Director of Pharmacovigilance (PV) Operations will:
• Provide input into the management of the regional PV Operations group, and input
in and leadership of Pharmacovigilance projects
• Contribute to overseeing quality and compliance of PV Operations in that region, as
well as for regional people, process and technology support of PV Operations
objectives
• Act on behalf of the PV organization and Parexel for all aspects of
pharmacovigilance (PV)
• Participate in providing high-caliber PV consulting to internal and external
stakeholders and client.
• Supports the Global Head of PV Operations in leading the training for PV
Operation group
• Supports market and business development on behalf of the entire PV
organization
• Provides regional input into PV business plan, development, budgets,
general and growth strategy, including global expansion
• Acts as technical expert of PV for internal and external stakeholders
• Trains and mentors/supervises Regional PV Operations staff and assists in
the training of Safety Physicians/Medical Monitors
• Public representation of the PV organization, including attendance and
presentations at international conferences as appropriate
• Works closely with colleagues in Medical Services Business Operations
and regional Safety Services Project Leaders on PV proposals and
projects
• Supports regional Medical Monitors as required
• Provides PV expertise and training to other Parexel personnel, as
appropriate
• Keeps current with professional and PV knowledge

Qualifications

Successful candidates will have:
• Knowledge of clinical, scientific and medical aspects of PV
• At least 10 years of significant experience in PV operations with a career progression to a leadership role
• Excellent knowledge of ICH, CIOMS and drug safety regulations in own region
(e.g. North America, Europe). Working knowledge of PV regulations in all other regions,
including Asia and Latin America
• Knowledge of the pharmaceutical and biotechnological world-markets
• Senior management skills, including performance management and budgeting
• Good general business/operational skills
• Good influencing and negotiating skills
• Excellent communicator

Knowledge and Experience:
• Significant experience in PV or related clinical, medical or scientific areas
• Line management experience
• Business and client experience
• Substantial clinical career, preferably on senior level
• Previous CRO experience is strongly preferred

East Coast candidates preferred; however, consideration will be given to others who meet the position requirements in other regions of the United States.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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