Pharmacovigilance Contracts Assistant/Administrator

Pharmacovigilance Contracts Assistant/Administrator 

Location: High Wycombe - Hybrid (2 or 3 days a week on site)

Duration: 12 Months

Hours: 37 per week

Pay rate range: Depending on experience 

Imagine your next project, working with Kenvue as a Pharmacovigilance Contracts Assistant. The Pharmacovigilance (PV) Contracts Assistant 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.

roles and responsibilities

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 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 collation of functional review and update to systems upon execution.

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

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

• 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.

Decision Making and Problem Solving:

Works as part of the global contracts team to support the framework for contract management. Works within the matrix of KMS and internal stakeholders to ensure that safety related agreements are correctly identified and contain the sufficient level of safety wording for the services provided taking into account applicable laws, regulations, resources, policies and internal company standards.

Working relationships:

Interfaces with: Safety Regional/Local, Procurement, Compliance Quality, BRQC, ICD and

Contract Owners as appropriate.

how to succeed

• A minimum of a bachelor’s degree is required (graduate level highly preferred) in a relevant discipline; life-sciences, healthcare field and/or legal qualification is preferred.

Required:

• 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

Desirable: 

• 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 drug safety organisation with operational responsibilities

•  Working experience of document production for a PV System Master File

benefits

This role offers a very competitive hourly rate. This contract will run for 12 Months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: Tabitha.Crabtree@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.