Job Description

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

Qualifications

Skills 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

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.