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 Senior PV/ Drug Safety Associate to join their International Pharmacovigilance Group on a 12-month rolling contract.
Inside IR35Onsite 2/3 days per week
Your new role
As a highly motivated individual, you will join their International Pharmacovigilance team as a Pharmacovigilance/ Drug safety Associate, where you will be responsible for supporting the Senior Drug Safety Manager for Nordics/Baltics in the management, and oversight of local Pharmacovigilance tasks in compliance with all applicable local regulations, guidance, and global business requirements. As a member of the International Pharmacovigilance (IPV) group, the Senior Associate will also support and facilitate the implementation and ongoing management of the overarching Pharmacovigilance strategy and operations as it relates to Affiliates in all regions.
- Maintains awareness of all Organised Data Collection Programs (ODCPs) (such as Patient Support Programs (PSPs) and Market Research Programs (MRPs)), Extended Access Programs (EAPs), Compassionate Use (CU), Registries, Digital and Social Media Activities that are relevant to the Nordics/Baltics region; ensures appropriate PV processes are in place (e.g. Adverse Event Collection); ensures adherence to the Global PV Governance structure and procedures.
- Authors and maintains PV-related training and ensures compliance and regular delivery to all affiliate staff, PV operations vendors and service providers, including but not limited to training pertaining to AE collection responsibilities.
- Authors local documents, such as Standard Operating Procedures (SOPs), literature screening strategy, and ensures content alignment with global procedures and local PV requirements; ensures regular updates of these documents as per the established review cycles and as required according to enhancement needs.
- Contributes as required for PV oversight, compliance management, and assist with late case investigations
- Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure.
- Contributes to the continuity of the critical PV activities in the Nordics/Baltics (including the establishment, maintenance and testing of the PV Business Continuity Plan).
- Contributes to IPV oversight of affiliates and vendors and including compliance and quality governance and oversight of safety report collection.
- Support the safety activities needed for launch and oversight of products as needed.
- Supports data gathering for PSMF updates under the remit of IPV.
- Support the oversight of training compliance as it pertains to vendors
- Support set up for new vendors
- Assisting with monthly reports on PV metrics.
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.
Experience of interacting with third parties e.g. PV operations vendors.
In-depth knowledge of global, regional, and local PV regulations and requirements.
Experience with Adverse Events Intake systems.
Experience of writing procedures, training materials, and effectively delivering training to a diverse audience.
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.
