Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Principal PV Policy & Governance Leader

Company: Roche
Location: Welwyn
Reference: 201811-128520
Closing Date: 19 Feb 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Who we areWe're innovation, curiosity and diversity - multiplied by 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we're constantly learning and growing - and seeking people who share these goals.The PositionThe Governance, Policy and QPPV Office Group supports the EU QPPVs in fulfilling a number of roles and responsibilities related to oversight of the PV system as outlined in the EU PV regulations. ...

Requirements:

Who we are

We're innovation, curiosity and diversity - multiplied by 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we're constantly learning and growing - and seeking people who share these goals.

The Position

The Governance, Policy and QPPV Office Group supports the EU QPPVs in fulfilling a number of roles and responsibilities related to oversight of the PV system as outlined in the EU PV regulations.   These include management of the key PV governance committee known as the Good PharmacoVigilance Practice Council (GVPC), production of the company Pharmacovigilance Master File (PSMF), and working with colleagues and PV experts both internally and externally to ensure timely implementation of PV regulations and oversight of PV system compliance for the Roche organisation.

As a forward thinking PV expert with the ability to work strategically and drive change, a PV (Pharmacogivilance) Policy and Governance Leader will lead and provide direction and expertise regarding PV system governance as well as assessment of and compliance with PV legislation. You will work as a member of the QPPV Office team, assisting colleagues with activities both within the group and across other groups and functions as necessary. You will build solid working relationships with key stakeholders, including Global Process Owners and leaders and managers in other functions and departments (e.g. Drug Safety, Regulatory, Quality Assurance, Medical Affairs, Commercial Organization and Affiliates) to identify and address issues relating to the global PV system. You will also interact externally with other PV experts and groups to enhance Roche's reputation and influence in the PV arena.

You'll need to exercise your leadership skills and expertise in this role. Providing colleagues with the expertise and direction required to translate regulation into workable solutions, you'll need to understand the regulatory environment and appreciate implementation in a complex matrix organisation. Collaboration with Global Process Owners will be critical, and you'll be factoring in strategic requirements and regulatory obligations. You'll also ensure that impact assessments are accurate and adequate in line with regulatory shift and current expectations.

You'll be attuned to trends and changes that shape regulation, able to analyse and anticipate future requirements for a diverse set of purposes. Contributing to oversight initiatives and providing input to concept papers and external regulatory projects, your expertise and leadership will be in demand across a number of stakeholder groups.

This is a senior position within the QPPV Office and would be an ideal "stepping stone" for anyone thinking about targeting a QPPV or Deputy QPPV role in their future career plans.

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 a scientific or healthcare discipline or an equivalent and substantial experience of pharmacovigilance functions and regulation, you'll bring a deep knowledge of EU and US PV requirements. With ability to work in a rapidly changing environment and a set of proven leadership skills, you'll be experienced in development and implementation of PV policies in complex environments. Alongside excellent analytical and systematic thinking, you'll be able to build strong and sustainable relationships across the organisation.

In return we offer a competitive salary plus the excellent benefits you would expect from a bluechip organisation, including a genuine interest in your development.

This role is a band 3

Closing date: Sunday 27th January 2019

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

Apply for this job: Principal PV Policy & Governance Leader

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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.