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Job Details

Senior PV Governance & Policy Scientist

Company: Roche
Location:
Reference: 3590891409
Closing Date: 19 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Pharmacovigilance (PV) Governance & Policy is responsible for Regulatory Requirement Intelligence and governance of the PV System as well as supporting the QPPV in fulfilling the roles and responsibilities in relation to the oversight of the PV system as outlined in the EU regulations. Reporting into the Global Head, PV Governance, Policy & QPPV Office, the jobholder plays a key role in the coordination of activities that enable effective oversight and governance of the PV System. ...

Requirements:

Pharmacovigilance (PV) Governance & Policy is responsible for Regulatory Requirement Intelligence and governance of the PV System as well as supporting the QPPV in fulfilling the roles and responsibilities in relation to the oversight of the PV system as outlined in the EU regulations.

Reporting into the Global Head, PV Governance, Policy & QPPV Office, the jobholder plays a key role in the coordination of activities that enable effective oversight and governance of the PV System. The jobholder is responsible for business activities that enable the Qualified Person for Pharmacovigilance (QPPV) to receive information that may affect patient safety or medical compliance.

Primary responsibilities may include:

• Ensuring the QPPV receives information that may affect patient safety or medical compliance, including managing messages and documentation within the QPPV mailbox.

• Planning and executing (cross functional) complex PV Governance & Policy led activities and initiatives as needed within the timeframes established, proposed cost and with highest quality

• Leading or participating in inspection readiness and process improvement initiatives to optimize medical compliance

• Reviewing selected new/revised PV legislation to identify any new requirements and performing impact assessments as needed. Coordinating and overseeing timely implementation  of the requirement as needed

• Working with other members of the PSMF team to ensure timely delivery of a high quality Pharmacovigilance System Master File (PSMF)

• Reviewing Pharmacovigilance Agreements for compliance with QPPV related obligations

 

Who you are

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. Where a job title is not considered the final definition of who you are, but the starting point.

Who you are

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.

With a degree in healthcare, a scientific field or the equivalent, you will have an impressive track record of delivering projects and initiatives that meet the demands of a highly regulated industry and you will possess a comprehensive knowledge of PV legislation and best practice. Experience in facilitating governance meetings with senior management is an advantage.

A proven critical thinker, able to find innovative solutions backed by rigorous analysis, your great attention to detail and thorough approach to achieving the highest standards in PV is essential.

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.

Who we are

Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Apply for this job: Senior PV Governance & Policy Scientist

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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