Pharmacovigilance Manager (young Dublin based pharma start-up )
This is a rare opportunity to join a young, exciting highly ambitious pharmaceutical company.
Our client is a specialty pharmaceutical company focused on providing therapies to patients with rare diseases. Their highly experienced seasoned management team has a broad range of experience in commercialization, acquisition, licensing, formulation and product development.
This is a newly created role that requires management of a busy PKV work load, and will include oversight of a US based vendor, as well as support for the US field force with Medical Information
- Ensuring that the Pharmacovigilance system has been implemented in compliance with established requirements
- Obtaining information for deficiencies and non-compliances within the Pharmacovigilance system
- Any required actions to ensure the QPPV is aware of any changes and updates to the PSMF including preventive measures
following audits, changes in existing products and outsourcing of Pharmacovigilance services, to guarantee the proper functioning of
the Pharmacovigilance system
- Manage/overview of all medicinal product safety profiles.
- Manage/overview of all emerging safety concerns.
- Manage/review conditions and obligations of MAH relating to the medical product.
- Manage/overview risk minimization measures.
- Review/sign-off on protocols of PASS, EU-RMP, PSUR etc.
- Involved in assessment of all safety concerns regarding medicinal products in the portfolio.
- Ensures quality of PV data posted to competent authorities.
- Responds to queries from competent authorities.
- Participates in other regulatory activities relevant to the risk benefit evaluation.
- Arrange local support for activities in countries where regulation states that the activities must be carried out locally.
- Ensures that necessary changes are made to the PV system as to promote, maintain and improve compliance with regulatory
requirements in the EEA.
- Oversight of the PV System of the MAH in terms of structure and performance.
- Verifies that the PV system operates in such a way the MAH is able to comply with PV obligations.
- Provides input pro-actively to ensure that all relevant procedures to meet regulatory requirements in the EEA are present.
- Communicates pro-actively all changes in the EEA of relevance for PV to MAH.
- Access to current versions of safety and related procedures and any relevant safety documents at all times.
- Assumes ultimate responsibility to Competent Authorities for the fulfilment of PV requirements.
- 24/7 point of contact for the Competent Authorities in the EEA. Availability to act, on behalf of MAH as contact point for PV
- Actively verifies that the PV and risk management system within the MAH are compliant with EEA regulations.
- Oversight of literature review, signal detection/trend analysis.
- Review results of literature searches that yield new, unlabeled ADR, signal detection/trend analysis, risk-benefit analysis etc.
- Oversees correct and complete development and regulatory submission of all periodic reports within the EEA.
- Provide and manage an emergency contact list of relevant staff at the MAH and EU QPPV.
- Conduct internal audit of the global PV system and licensing partners in line with EEA expectations
- Shares/trains deputy QPPV on product information.
- Provide access to medical expertise for Deputy QPPV.
You will have a relevant academic qualification (Md, PharmD, RGN) and possess a depth of experience in Drug Safety operations,
Pharmacovigilance and Project Management
Experience in Drug Safety Applications and Regulatory compliance applications a plus
Knowledge of 21 CFR Part 11 guidelines, EMA GvP modules, Computer system validation guidelines
Experience in Service Delivery of Small, Medium and/or Large sized Drug Safety projects
Excellent relationship management skills
Strong project management skills, with a keen desire for execution
Strong analytical and strategic thinking abilities
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross-department communication. Ability to document and communicate problem/resolution and information/action plans.
Proficiency in use of ARISg or equivalent Drug Safety Database (ie ARGUS, AERS, etc.) with strong expertise in Microsoft office
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrated flexibility within a dynamic, fast-paced, cross-functional team
Demonstrated ability to complete multiple tasks concurrently and deliver results in a challenging environment Ability to work under stringent deadlines.
This role will include some international travel
Cv to Gerry@rftgroup.ie