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Job Details

PV Process Leader

Company: Roche
Location:
Reference: 3246393332
Closing Date: 04 Dec 16
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

> This position is within Product Development Safety area, in Scientific Enablement & Processes (SEP) , reporting to the Group Head PV Processes. The Scientific Enablement & Processes (SEP) organization is responsible for subject matter leadership and ownership of the critical PV processes owned by PDS and the development/acquisition of new methodologies, tools, and approaches for scientific enablement. ...

Requirements:

>

This position is within Product Development Safety area, in Scientific Enablement & Processes (SEP) , reporting to the Group Head PV Processes. The Scientific Enablement & Processes (SEP) organization is responsible for subject matter leadership and ownership of the critical PV processes owned by PDS and the development/acquisition of new methodologies, tools, and approaches for scientific enablement.

Primary Responsibilities & Accountabilities include but are not limited to:

  • Serving as Global Process Owner and/or Business Process Owner for one or more assigned process(es)
  • Responsible lead role in the design, development, maintenance & support of one or more core PDS processes of the highest business complexity, that are required to deliver effective scientific safety activities and/or PV system activities (e.g. global ICSR management, signal management, risk management, etc.)
  • Collaborating closely with the Scientific Enablement Leaders and guiding other SEP staff via the Center(s) of Excellence or other available mediums to achieve scientific innovation and enablement in their assigned process(es)
  • Serving as a team leader/chairperson of expert working groups or committees, required to support assigned processes or lead improvement programs
  • Influencing externally in the assigned areas of expertise (e.g. involvement in expert working groups or industry associations, external policy influence) and promoting Roche activities externally (e.g. via publications or scientific conferences)
  • Maintaining expert knowledge of key regulatory and legislative changes and scientific best practices in the assigned SME area(s) and ensuring future changes are anticipated and planned

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.

We are looking for a professional with MD or a degree in a life science or healthcare-related discipline (e.g. PharmD, nursing, dentistry, etc) and relevant experience in pharmacovigilance and/or a clinical safety-related role (typically 7+ years of experience).

Experience, Skills, Knowledge:

  • Demonstrable ‘hands on’ experience of delivering or managing safety and pharmacovigilance activities described by the assigned safety processes is desirable.
  • A broad understanding of pharmaceutical drug development is advantageous.
  • Good knowledge of regulatory pharmacovigilance requirements and guidelines published by the major global Health Authorities (e.g. FDA, EMA, MHRA, etc).
  • A general understanding of pharmacoepidemiology and its potential application to safety related activities would be an advantage
  • Prior experience in project management and/or business improvement is desirable
  • Awareness of ‘benefits realization’ approaches and change management activities that can ensure process improvements are sustained & measured. 
  • Ability to operate effectively in, and lead as needed, multi-functional matrix teams

Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

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: PV Process 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

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