Pharmacovigilance Specialist, Eurofins Lancaster Laboratories at Kalamazoo
About the job
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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
- Conduct daily quality review of cases documented in the global pharmacovigilance database associated with reported adverse experiences to ensure accuracy, timely submission, and compliance with current pharmacovigilance (PV) and SOP requirements
- Run regular reports to: identify cases to be quality reviewed, conduct trending analysis, identify cases that have not been approved, etc.
- Provide timely feedback to case owners and follow-up when case corrections are requested
- Respond to case owner questions on regulatory guidelines, case completion and relevant practices
- Proactively look for and suggest improvements to current regulatory processes, including all pertinent working practices; work with Global PV to implement any efficiencies to the case management process (data entry, medical investigation, customer responses and case follow-up)
- Conduct regulatory training of departmental staff, contractors and external vendors as requested
- As part of the Audit Team, perform duties specific to ensuring Global PV remains audit-ready, including timely SOP reviews and updating, creating and retiring SOPs, take part in internal inspections
- Collaboratively work with GMS and global PV colleague
- Participate in regulatory/compliance related discussions, including but not limited to staff meetings, Clinical Forums, PV team meetings
- Maintain familiarity with veterinary practice operations and terminology
- Awareness of documented agency regulations and guidelines (CFR, GFI and VICH guidances related to Pharmacovigilance)
- Remain fluid with the use of PV Works and provide training to colleagues, serving as a subject matter expert
- Complete ongoing required training within stipulated time-frames in order to maintain strong knowledge of products, programs, policies and procedures
- Participate in ongoing departmental and weekly team meetings
- Manage multiple tasks simultaneously in a consistently changing environment
- Highly detail-oriented approach to work
- Must be self-motivated and disciplined
- Ability to work independently and as a team member
- Excellent verbal, written, and interpersonal communication skills
- Excellent computer skills including proficiency in Microsoft Office applications
- Flexibility and ability to handle multiple tasks simultaneously
- Ability to display high levels of initiative, effort, and commitment in order to successfully complete projects and assignments
- Must be able to influence without authority
- Must be able to deal with people at all levels inside and outside of the company
- Bachelor’s degree preferably in Animal Science or Regulatory discipline or CVT with at least three years relevant experience in an equivalent field or regulatory environment.
- Experience in human or veterinary Pharmacovigilance databases, case entry or case review
Position is full-time, first shift.
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
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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