Manager QPPV Office

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

We have an exciting opportunity for a Manager, Qualified Person for Pharmacovigilance. This role can be remote based across multiple European locations.

Responsibilities:

• Preparemaintain projectrelated documents
• Compile the PSMFs (act as PSMF Coordinator) and ensure reviewapproval by the QPPV and timely submission to authorities, as needed.
• Quality check the PSMF prior to QPPV approval.
• Work on Pharmacovigilance projects for clients, based on experience and qualification. Includes negotiation of agreements, updates and terminations for all types of PVAs: SDEAs, PV Service Agreements, Quality Technical Agreements.
• Perform administrative tasks, as needed to support the QPPV and the PER PV GOV Practice Area
• Act as Project lead (PL) for small projects (e.g. only QPPVPSMF or PVA service in scope).
• The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks in line with their abilities, qualification and training, if required.

• Education:

  • University degree in Life Sciences (preferred but not essential)

  • .

    Experience:

    • Several years experience and profound knowledge in the field of pharmacovigilance (global PV systems)
    • Expertise, experience and knowledge of relevant legislative and nonlegislative guidelines and requirements on pharmacovigilance.

    • Skills:

      • Proved ability in leading, mentoring, managing and motivation of staff (for project teams)
      • Ability to train and support juniornew colleagues in daily activities; ability to lead small projects with clearly defined scope
      • Ability to manage internal and external (client) relationships on operational daytoday working level as well as clients team lead level.
      • Good communication skills (written and verbally); ability to communicate issues and propose appropriate solutions to decision makers. Good presentation skills.
      • English (business level) fluent.

      • What Cencora offers

        ​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

        Full time

        Affiliated Companies

        Affiliated Companies: PharmaLex Spain S.L.U.

        Equal Employment Opportunity

        Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

        The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are nondiscriminatory.

        Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returned