Global Pharmacovigilance Signal Management Sr. Associate
Eurofins Lancaster Laboratories Professional Scientific Services, LLC

Company Description

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you're looking for a rewarding career, a place to call home, apply with us today!

Job Description

• The Pharmacovigilance Signal Management Sr. Associate will serve as a core member of the safety team and is responsible for performing proactive pharmacovigilance activities to evaluate safety data and signals for marketed products.
• This includes performing signal detection and safety management committee activities, contributing to the review of aggregate safety reports, assisting with ad hoc regulatory responses, facilitating signal management process for assigned products (i.e., executing signal detection queries, signal tracking)
• Build and maintain technical files within the global signal management system
• Utilize technical tools with the Pharmacovigilance suite of software solutions
• Provide innovative ideas and solutions to evolving signal detection and signal management landscape

• B.S. degree required
• Other advanced degree (MS, MPH, PhD) in science such as Biology, Epidemiology, Data Analytics, Regulatory Affairs, or related science is preferred.
• Minimum 2 years' experience navigating databases and performing queries, exporting data.
• Good knowledge of US and EU pharmacovigilance regulatory requirements with experience in interpretation of regulations, guidelines, and policies preferred.
• Experience in preparation of regulatory submissions and knowledge of pharmacovigilance practices preferred.
• Problem solver with an ability to take ownership for issues and have the ability to suggest opportunities for continuous improvement
• High level of competency using Microsoft Office suite - with demonstrated high level competence of working in Microsoft Word, Excel, Power BI
• Good organizational skills and attention to detail
• Excellent written and verbal communication skills, fluent in English (verbal and written)
• Ability to evaluate and synthesize scientific data (analytical thinking)
• Team player with ability to function in a cross-functional environment
• Self-motivated, able to prioritize and plan effectively, and independently, with minimal supervision
• Curious, self-starter with a strong interest in data analysis and patient safety
• Pragmatic and agile, with mature business acumen

• Position is full-time, first-shift.
  
• Candidates currently living within a commutable distance ofKalamazoo MIare encouraged to apply.
  
• What we offer:
  
  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
  • Yearly goal-based bonus & eligibility for merit-based increases
  • #LI-EB1