Our client has identified a need for an experienced and smart Pharmacovigilance leader with experience working within a fast-growth pharmaceutical and/or device setting, able to manage the PV Vendor relationship and work with the clinical development team to ensure optimal compliance and safety procedures are maintained across existing and new products within the portfolio. Currently focused on the US market, with a need for depth of knowledge regarding the US regulatory landscape, it is expected the product-set will expand in the other territories, therefore global PV experience would be desirable.
As the PV Safety Officer and PV Vendor Manager, you will;
- Provide vendor oversight, including tracking key performance indicators (KPI’s), and ensuring the quality of the work performed by the vendor meets all expectations.
- Support workflow compliance, Health authority submissions, corrective and preventative actions working closely with the PV vendors, as well as internal stakeholders within Safety, Clinical Development, Compliance, and Commercial areas of the client.
- Perform evaluation, processing, and submission of adverse event (AE) (clinical trial and post-marketing).
- Prepare and deliver presentations at SMT meetings; participate in clinical study team meetings as appropriate for assigned products.
- Drive development and maintenance of Aggregate Reporting (i.e. PSURs/PBRER).
- With support from Safety Lead, you will: Perform signal detection activities for assigned products in line with the approved safety /surveillance plan; Perform signal evaluation for any identified signals, and author the safety evaluation report.
- Prepare and review safety documents (Safety Management Plan, etc.), respond to the health authority or other stakeholder queries, etc.
- Provide safety input to protocols, investigator brochures, safety summaries, clinical study reports.
- Demonstrate excellent knowledge of PV Operational execution.
- Conduct safety reviews and participate in any regulatory audits or pre-audit preparation.
- Ensure SOP’s are developed and complied with, both in terms of vendors and internal stakeholders, and that appropriate compliance reporting is put in place.
- Have solid understanding and maintain knowledge of pharmacovigilance regulations, guidelines, reporting requirements, scientific literature, and competitor products safety profiles.
Your background will include the following elements;
- A minimum of a Bachelor’s degree in nursing, pharmacy, life sciences, healthcare, or a related field, with a Master’s preferred.
- Certification in Pharmacovigilance or other safety protocols preferred.
- Demonstrated experience working in a Drug Safety/PV role with responsibilities for managing vendor relations for investigational and marketed products.
- Knowledge of both medical devices and biopharmaceutical products is preferred.
- Demonstrated knowledge of PV science operations, the US-regulatory landscape, and associated processes are required. Global PV regulatory experience preferred.
- Demonstrated knowledge of the medical device and drug development process.
- Experience working within a small team, handling a wide array of tasks and responsibilities, and comfort with providing support and cover to colleagues, even if some of the tasks are outside of your remit.
- Comfort with shifting priorities and ambiguity common in fast-growth companies.
- Proven exceptional written and verbal communication skills, including evidence of leading interactions with vendors, regulatory authorities, internal stakeholders, and senior leadership.
- The ability to marry the competing interests of the Commercial organization and PV to ensure safety is prioritized while maintaining an understanding of market realities and demands.