This innovative Irish biopharmaceutical client are seeking an experienced Pharmacovigilance Operations Specialist to join the PV team at their Dublin headquarters. This organisation develops products focused on rare and genetic diseases, and have robust pipeline of late stage clinical products. Having recently signed off on an exciting acquisition, they are going from strength to strength. This is a permanent opportunity with a hybrid working model available.
The PV Operations Specialist is responsible for supporting the Global Pharmacovigilance team with expertise in global safety database set up and data migrations. The role will facilitate PV System integration across all products.
Duties and responsibilities of the PV Operations Specialist will include but are not limited to:
- Define data migration plans, templates, and standards that significantly improve the quality of data migrations into the Global Safety Database.
- Provide current status of product availability in territories to relevant vendors on an ongoing basis.
- Oversight of xEVMPD submissions performed by the vendor.
- Oversee/manage an electronic global safety database for tracking, storing, and reporting adverse events of all investigational and future marketed products.
- Support PV vendor management oversight activities including day-to-day oversight, review, and evaluation of the vendor performance and quality.
- Provide subject matter expertise to our external clients as well as internal stakeholders with respect to PV system integration and data migrations.
- Support the drafting and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity.
- Ensure compliance with PV regulations per FDA, EMA, ICH, etc and with PV and Risk Management policies and procedures.
- Provide PV input to Clinical Operations, Regulatory Affairs, Quality Assurance and partners/vendors as required.
- Participate in internal audits and global regulatory inspections as a SME for specific PV topics and processes.
You will have skills and experience in the following:
- BSc and 3+ years' experience in pharmacovigilance
- Minimum of 2 years' experience in admin-level operation of a 7th generation safety database or greater (e.g Argus or ARISg).
- Strong Pharmacovigilance and drug development foundation, including knowledge of clinical trial safety regulations and post-marketing including case processing and expedited reporting rules.
- Working and technical experience with set up of global safety databases including data migrations.
- Understanding of xEVMPD requirements desirable.
- Excellent understanding of PV regulatory environment with working knowledge of FDA, EMA and ICH regulations, Guidance, best practices, and Good Pharmacovigilance (GVP).
- Proven ability to analyse and present scientific and medical data.
- Requires a high level of initiative and independence.
- Excellent collaboration skills to optimise the relationship with internal and external partners.
- Must have excellent written and oral communication skills, resourcefulness and personal organisation skills.
- Computer literacy with proficiency in Microsoft Word, Excel, PowerPoint.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.