Deputy EU QPPV Head (m/w/d)

Division Global Drug Development
Geschäftseinheit CMO & PATIENT SAFETY GDD
Standort Wehr
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Unbefristet
StellenID 237403BR


Stellenbeschreibung

Purpose of the job:

To fully support the EU Pharmacovigilance Qualified Person (EU QPPV) with delegated tasks in order to drive pharmacovigilance systems compliance and required product safety oversight. The role requires full legally liable deputization for the EU QPPV during her absences

Responsibilities:

• Provide strategic input to global and local pharmacovigilance systems in
order to promote, maintain and improve compliance. Represent the QPPV
Office in activities developed towards full integration of Sandoz Generics and
Biosimilars processes governing pharmacovigilance. Ensure QPPV’s
oversight on all aspects of safety and pharmacovigilance processes for
Sandoz` products
• Align country drug safety activities through leading the Regions and Global
QPPV/Country Patient Safety Head (CPSH) networks to promote local
regulatory compliance. Ensure timely and complete communication of drug
safety or compliance related information to and from QPPV Office and
CPSHs
• Serve as key go to person in the QPPV office to assess licensing agreements
and provide input. Attend licensing partner due diligences and audits as
required and where appropriate
• Stablish collaboration with Development QA and PV Operations to ensure
continuous QPPV oversight regarding strategic vendors
• Build in quality through review and approval of health authority
pharmacovigilance outputs (RMP, PSUR, PASS determinations, ad hoc
requests) if needed
• Support EU QPPV/Head of QPPV Office and Lead Strategy and Operations
as required in audits/inspections and response processes
• Provide appropriate input into urgent regulatory actions with focus on
EU/EEA and information flow to the QPPV Country Patient Safety Head
network, as required (together with Therapeutic Area Safety Leads)
• Maintain up-to-date awareness of evolving pharmacovigilance-related
legislation with focus on the EU/EEA to provide strategic support to the Head
QPPV Office and EU QPPV
• Together with other members of QPPV office support the Senior Manager
QPPV Office and/or Lead Strategy and Operations QPPV Office to ensure
that the Pharmacovigilance System Master File is kept current and submitted
to HAs as required. Together with all members of QPPV office develop and
facilitate access to all information sources maintained to oversee the structure
and performance of the Novartis group of company`s pharmacovigilance
system
• In the absence of the EU QPPV and when formally designated as acting EU
QPPV, act as a point of contact in the Novartis` Group of companies for the
EMA and any national competent authorities (as required) on a 24 hour basis
and manage/cascade safety related requests for systems or drug safety
related information to ensure any requests are answered fully and promptly



Research & Development


Mindestanforderungen

Requirements:

• PharmD or PhD in Life Sciences or MD
• Excellent knowledge of English, both oral and written and knowledge of a
second European language is an advantage
• High level of expertise in pharmacovigilance ideally including medical safety
(min 7 years), and preferably experience in a major country
• Excellent knowledge of global regulatory requirements relating to
pharmacovigilance
• Pharmacovigilance systems experience (covering compliance, databases,
procedures, QA, training)
• Experience in the area of audits/inspections
• Ability to effectively communicate and influence at all levels
• Proven track record of successful project management
• Stakeholder/matrix management

What do we offer?

"Attract, develop and retain best talents!"

We align our activities with these goals. We therefore offer our employees motivating conditions and attractive remuneration. In addition, we undertake a variety of initiatives for these goals in order to offer talented people far-reaching development and career prospects within the Group. With a balanced mix of tangible and intangible benefits, we can meet the needs of our employees.



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