Job Description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....





ClinChoice is searching for a

Pharmacovigilance Contracts Administrator

Consultant

to join one of our clients.

Work Location

: Location - UK (3 days in High Wycombe office, 2 days remote per week)





ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.

Main Job Tasks and Responsibilities:

The Pharmacovigilance (PV) Contracts Administrator provides administrative support for commercial/service/technical safety related agreements which are created to ensure appropriate collection and processing of safety data from external business partners and vendors to fulfil regulatory requirements.



Provide administrative support for contract management oversight for safety related commercial/service/technical agreements by



Review and assist where necessary with creating templates or standard wordings on safety related matters and the maintenance of such templates.



Assist with the collation of information from the various regions to enable teams to perform gap analysis where PV agreements are required and to identify partners for an audit.



Assist with contract database management including but not limited to uploading contracts, periodic review, renewals, terminations, update requests and revisions.



Support the development of new PV Agreements on an ad hoc basis including to collation of functional review and update to systems upon execution.



Assist with creation and distribution of training materials for contract management.



Assist with the co-ordination of monthly contract reviews and where necessary assist with these and support communication for further assessment by PV Lead.



Support the management and coordination of team mailbox which includes liaising with internal stakeholders as point of contact for queries and training regarding safety relatedness, PSMF relevance and inclusion of safety language to include Contract Owners, LSOs, Regional Leads, Database Owners, BRQC and functional representatives.



Assist where necessary with the preparation of contract listings for the PV System Master File

Education and Experience:

Strong organizational and coordination skills


Demonstrated experience in program management, preferably in the pharmaceutical business environment. Demonstrated problem solving ability. Strong verbal and written communication and computer skills

A minimum of a bachelor's degree is required in a relevant discipline; life-sciences, healthcare field and/or legal qualification.



3 to 5 Years PV (with minimum 1 year PV contracting experience)

Knowledge, Skills, Abilities:

Desirable attributes:

Knowledge of applicable law and regulations governing pharmacovigilance on a global level


Proficiency with contract language and standard legal terms and conditions for commercial and vendor contracts Working experience in a safety organization with operational responsibilities Working experience of document production for a PV System Master File and Contracting Systems

The Application Process

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Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

--------------------



ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

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Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.



ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words:

PV, Pharmacovigilance, Agreement, contracts, PV System Master File , Contracting Systems





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