SENIOR SCIENTIST PATIENT SAFETY

The Life Science department of ALTEN continues to grow. We are now looking for you, a Senior Scientist who will be working for one of our biggest customers.

•Support and drive discrete improvement projects relevant to the scope of the QPPV function.
•To provide support for maintenance of Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS) and PRAC monitoring activities.
•Provide project management support for dedicated project(s).

Typical Accountabilities:
• Support and drive PV Excellence by inputting to ad hoc allocated tasks in relation to:
• Developing and maintaining framework(s) for content quality measurement and oversight.
• Assessing the effectiveness of initiatives with identification of subsequent further improvement actions as needed.
• Developing standardised best practice templates, authoring instructions and guidance for production of Patient Safety outputs.
• Promoting and ensuring Patient Safety outputs are produced in accordance with High Performance Authoring (HPA) principles.
• Implementation of standards and skills with Patient Safety Therapeutic Area teams and individuals in close collaboration with Process Area Leads (PAL) and Process Owners (PO).
• Ensuring the adoption of standards and skills by developing and providing process competence and capability build training to functional groups within Patient Safety.
• Providing specialist knowledge and support to be recognized as experts and source of reference for safety teams and other stakeholders.
• Contribution to the definition and assessment of measurable objectives and delivery targets.

Provide support for:
• Maintenance of Pharmacovigilance System Master File (PSMF)
• Summary of Pharmacovigilance System (SPS)
• Monitor PRAC outputs per SOP

Provide project management support for dedicated projects

As needed:
• Upon request participate and/or support activities for GVP audits/inspections

Education, Qualifications, Skills and Experience:

Essential:
• Health professional degree (MD, PharmD, RPh, RN, or related degree) or master’s degree in life sciences, or related field
• Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
• Extensive operational experience in production of core safety outputs
• Good knowledge and comprehension of relevant pharmacovigilance legislation
• Excellent medical writing skills
• Excellent communication skills
• Experience and ability to develop and implement new standards and best practices
• Strong project management skills
• Proven ability to lead teams and collaborate in a continuous improvement
• Good strategic thinking capability

Desirable:
• Regulatory strategy knowledge and experience
• Clinical development knowledge and experience
• Lean Sigma experience

ABOUT ALTEN

ALTEN is a consulting company that develops and delivers expertise for world-leading companies with consultants in technology, IT and biochemistry. We are located in over 28 countries, have our headquarter in Paris and have more than 37 200 employees, of which 88 percent are engineers. In Sweden, we have over 1 700 employees and work from offices in twelve locations. Our clients are found in industries such as Automotive, Energy, Telecom, Industry, Aerospace & Defence and Life Science, where our consultants operate throughout the product development chain.

Welcome to read more about us at alten.se or please contact Oscar Sundell at Oscar.Sundell@alten.se for further information.