Associate II, Pharmacovigilance - UK/EU - Remote

Worldwide Clinical Trials; United Kingdom; Remote; GBP 30,000 - 40,000; Full time

Job summary

A leading global Clinical Research Organization is seeking an Associate II for Pharmacovigilance to ensure drug safety. This remote position involves various responsibilities including reviewing safety data and generating regulatory reports. Candidates should have a relevant Bachelor's degree and at least one year of experience in pharmacovigilance, alongside strong communication and organizational skills.

Qualifications

• 1 year of pharmacovigilance experience required.
• Equivalent combination of education and experience acceptable.
• Excellent written and verbal communication skills needed.

Responsibilities

• Author Safety Management Plan for assigned studies.
• Review incoming SAE data for completeness and accuracy.
• Generate regulatory reports and perform safety submissions.

Skills

Medical terminology

Clinical assessment

Database management

Communication skills

Organizational skills

Education

Bachelor’s degree in a science-related field

Tools

MS Office applications

Job description

Associate II, Pharmacovigilance - UK/EU - Remote

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

What Pharmacovigilance department does at Worldwide

Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team comprises a dynamic group of individuals with extensive experience within the Drug Safety world. Watching drugs progress from First in Human Administration to global regulatory approval, we can be a part of the entire lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze, and submit to Investigators, Ethics Committees/IRBs, and Regulatory Agencies furthering clinical drug development!

What you will do

• Author Safety Management Plan for assigned studies
  
• Attend internal and client meetings as appropriate
  
• Review incoming SAE data for completeness and accuracy
  
• Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
  
• Generate queries for missing or unclear information and follow-up with sites for resolution
  
• Perform QC of SAEs processed by other PV Associates
  
• Generate regulatory reports and perform safety submissions as needed
  
• Prepare and submit periodic safety reports as needed
  
• Maintain knowledge and understanding of safety related regulations and guidelines
  

What you will bring to the role

• Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
  
• Good understanding of computer technology, and management of relational database systems, including extraction of data
  
• Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment
  
• Excellent organization skills and ability to handle multiple competing priorities within tight timelines
  Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibility
  

Your experience

• Bachelor’s degree in a science-related field, nursing, or equivalent
  
• Minimum of 1 year of pharmacovigilance experience (pre-approval clinical trials)
  
• Equivalent combination of relevant education and experience
  
• Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
  
• Excellent written and verbal communication skills
  
• Excellent organization skills and attention to detail
  

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

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