Your new company
My client, a global pharmaceutical and biotech company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life by preventing, alleviating, and curing diseases. They have a wide pharmaceutical portfolio, specialising in some of the following areas: Oncology, neuroscience, and rare diseases.
There is an opportunity for a Pharmacovigilance / Drug Safety Associate to join their International Pharmacovigilance Group on a 12+-month contract.
Inside IR35
Onsite 2/3 days per week
Your new role
As a highly motivated individual, you will join their International Pharmacovigilance and Global Case Management team as a Pharmacovigilance/ Drug safety Associate, where you will be responsible for supporting the team to perform daily monitoring of expedited submissions and implementation of the overarching Pharmacovigilance (PV) operations as it relates to Company's Partners, Distributors (International Partner Markets [IPM]), Vendors and the wider PV network that includes stakeholders worldwide and other, functional groups including but not limited to Worldwide Medical, Commercial, Quality, Regulatory and Global Marketing.
* Contributes to oversight of the Company's Partners, Distributors, Vendors, including metrics, and review of IPM trackers.
* Supports the Organised Data Collection Programs (ODCPs) process for AE collection to ensure consistency with regulations and with departmental goals and objectives.
* Supports the collection, analysis, communication, and operational change management process for Regulatory Intelligence related to PV in the Distributor Network.
* Delivers and monitors training, as required, to the Distributor Network employees
* Prepares data for Distributor Network quarterly meetings and follow-up of action items.
* Performs administrative tasks such as:
o attend routine PV meetings for training purposes and ensuring compliance with all assigned trainings.
o produce regular and ad hoc reports ensuring compliance with KPIs.
o investigate and address compliance issues.
o gather and document training requirements from meetings and feedback.
o perform ongoing day-to-day tasks including coordination of training services, reconciliation activities, maintenance of meeting minutes and any other ad hoc projects/activities assigned to meet evolving business needs.
o review queries and coordinate responses related to activities performed by the Distributor Network.
o adhere to local policies related to flexible working.
Additional responsibilities assigned on an ad-hoc basis are as follows:
* Supports IPM leadership in the development and ongoing management of technology solutions used to compliment the oversight and day-today PV activities conducted across the Distributor network.
* Contributes to the mechanisms needed to oversee appropriate training of case intake procedures and systems to ensure adequate AE collection in the Distributor Network.
* Assists with the controlled document management lifecycle, providing input and monitoring of activities governed by Standard Operating Procedures (SOPs), Job Aids, Distribution Agreements (DAs), Regulatory Services and PV Agreements (RSPVAs), R&D Business Processes, Work Instructions, and reporting forms.
* Performs case review activities assigned by supervisor to ensure on-time completion of trackers.
* Supports audit and inspections including follow-up of open action items and investigations as related to the Distributor Network.
What you'll need to succeed
You will hold a minimum of bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences.
You will have hands-on experience in drug safety/pharmacovigilance in a pharmaceutical industry setting.
Good administration experience
Experience of interacting with third parties e.g. PV operations vendors are a plus.
Knowledge of global, regional, and local PV regulations and requirements.
Experience with ICSR submissions to Health Authorities, Ethics Committees, and Investigator Sites.
Experience with gateway submissions i.e. E2B, R2 and/or R3 submissions to Health Authorities, business partners, etc.
Strong communication and organisational skills, including the ability to prioritise independently.
Knowledge of common safety database systems, i.e. Argus and ArisG
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.