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Associate Director, Pharmacovigilance Operations

Employer
Parexel
Location
Romania
Salary
Competitive
Start date
17 Oct 2021
Closing date
14 Nov 2021

View more

Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

    Company

    Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

     

    Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

     

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    GB

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