Roche

Deputy Qualified Person for Pharmacovigilance

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
22 Oct 2018
Closes
20 Jan 2019
Ref
201809-121044
Discipline
R & D
Leading on compliance matters, you'll put the patient at the centre of pharmacovigilance activities. This role demands a high level of personal ethics and integrity, taking responsibility for inspection readiness and handling of safety information. You will be accountable for the oversight of Pharmacovigilance system in the UK. You'll maintain a compliant set of systems, collaborating with UK partners and beyond to keep oversight of the risk and benefit profiles of Roche products Act as the primary contact for pharmacovigilance inspections.

You will be responsible for the timely submission of pharmacovigilance-related documents in accordance with statutory requirements to ensure the required quality of the PV data submitted to the MHRA and other competent authorities.

Responsible for study and programme oversight, you'll ensure relevant reporting processes and documentation are in place to support study activities and will provide safety science teams with relevant PV information. A key point of contact for authorities, you'll manage safety queries and issues, maintaining correspondence letters and processes. Aiming to create efficient authorised access to safety information, you'll ensure the organisation and availability of contract details, reports, commercial agreements and regulatory submissions.

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

A GMC registered physician with a License to Practice is preferred, alternatively other healthcare professional or other strong scientific background with strong Pharmacovigilance experience , you'll bring a deep knowledge of clinical medicine and pharmaceutical regulation. A team leader with management experience, you're able to influence stakeholders with compelling evidence and engagement, including the MHRA. Ideally you will have experience of working within operational PV, preferably in a QPPV office. Experience in Medical Affairs role in Pharmaceutical industry will be an asset.

If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.  In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression. 

To be considered for this position, please apply using the link below.

When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety

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