Contractor, Pharmacovigilance Emeac

Join Us | Reata Pharmaceuticals
As a commercial pharmaceutical company, we are committed to positively impacting the lives of patients with life-threatening diseases.

With rigorous science and research as our foundation, we are a diverse team of problem solvers, trailblazers, and people who want to make a difference in the lives of patients.

Having received our first drug approval in the U.S., we are focused on global expansion. In 2021, we established our European regional office in Zug, Switzerland.

What You Will Do | Scope of Work

As a Contractor for Pharmacovigilance in EMEAC, you will support the overall safety strategy and major safety deliverables across Reata's full portfolio of clinical development and forthcoming commercial products in EMEAC.

You will lead the oversight of local pharmacovigilance operational activities in the EMEAC, in coordination with the Head of Postmarketing pharmacovigilance.

This includes oversight of local intake and follow-up of postmarketing adverse events by internal and/or external partners, oversight of local pharmacovigilance responsible persons, and ensuring appropriate submission of ICSRs to EMA and local European health authorities.

Additionally, you will be involved in various pharmacovigilance safety-related activities.

Specific duties may include the following:

• Assist with analyzing, summarizing, and presenting safety data
• Support Adverse Event collection and submission of ICSRs from postmarketing safety studies, safety registries and other safety commitments
• Support the screening of local literature for adverse events and/or PSURrelevant articles
• Provide support and input to the planning, preparation, writing, and review of safety reports
• Support company activities in response to emerging safety issues
• Coordinate with Quality Assurance to ensure compliance with GVP modules and support local pharmacovigilance inspections
• Perform assessment of local expectedness for ICSR submission
• Assist in the oversight of PV agreements with EU vendors
• Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate
• Assist in AE training of EMEAC internal and external partners/vendors
• Additional duties to support all other pharmacovigilance activities that impact the EMEAC, as assigned

This assignment is initially planned for a 12-month period.

What We Are Looking For | Experience**- 8+ of relevant experience working within the pharmaceutical industry in pharmacovigilance operations in post-marketing environment

• Strong working knowledge of case management and processing
• Experience in using ARGUS or other safety databases is preferred
• Experience with quality assurance and compliance for drug safety
• Experience with European safety reporting regulations
• Experience with Regulatory Authority Inspections (PV and GCP)
• Experienced with liaising with local pharmacovigilance responsible persons and QPPV

What We Are Looking For | Skills & Work Style**- Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations

• Coding familiarity
• PowerPoint slides preparation and presentation familiarity
• Ability to work on processes collaboratively and independently such as responding to regulatory agency requests
• Strong team player, a fully engaged, handson professional capable of working collaboratively and independently
• Excellent verbal and written communication skills

What We Are Looking For | Education**- Life Science Degree required. Pharmacist preferred.

Location | Travel**- Remote or hybrid from Switzerland, Germany, Italy, or France

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