Director, Pharmacovigilance Operations

Incredible opportunity to bring your PV Leadership and Global Program Oversight experience to Parexel!

In this highly visible leadership role, you will work strategically with a top biopharmaceutical company to help bring their strategies forward and, ultimately, make an incredible impact on the lives of patients. You will use your PV expertise to serve as a trusted partner to this client and draw upon your leadership talent to inspire and motivate our highly experienced PV team aligned with this client’s programs. All while gaining tremendous exposure to a variety of therapeutic areas and cutting-edge product and compounds.

The Director 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

• Mentor 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 QualificationsSuccessful 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, project/program management experience, budgeting, issue resolution, etc

• 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 or previous mentoring/staff development experience

• Business and client experience

• Substantial PV career, preferably on senior level

• Previous CRO experience is strongly preferred; however, candidates with pharmaceutical or biotech experience will also be considered

Massachusetts or New Hampshire based candidates with proximity to Boston are strongly preferred due to the need to meet with the client, as needed; however, consideration may be given to others in the greater New England region who meet the position requirements and have the flexibility to travel to Boston when needed for client meetings EEO DisclaimerParexel 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.