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Skills: Pharmacovigilance, SAE Processing, Safety Management Plan Authoring, Regulatory Reporting, Data Entry
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 ta…
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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 ta…
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 ta…
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Specialist, Regulatory & Site Activation - Australia - Remote
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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 ta…
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 ta…
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$50k–$99k/yr
Full-time
bachelor degree
Competitive Benefits Package
Posted 26d ago
~40 hrs/week
Remote in United States
Responsibilities
Responsible for the collection, processing, evaluation, and reporting of Serious Adverse Event (SAE) data according to regulatory guidelines. The role involves authoring Safety Management Plans and performing quality control on safety data processed by other associates.
Requirements
Requires a bachelor's degree in a science-related field or nursing and a minimum of one year of pharmacovigilance experience in pre-approval clinical trials. Candidates must be fluent in English and proficient in MS Office applications.
Full job description
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 the Associate, Pharmacovigilance does at Worldwide
Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions.
Serves as Lead PV Associate on small to moderate sized studies that are simple to moderate in complexity and scope of work with support from senior staff.
What you will do
Author Safety Management Plan for assigned studies
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
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 responsibilities
Ability to anticipate needs and follow through on all assigned tasks
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
Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines
Ability to work independently, prioritize work effectively and work successfully in matrix team environment
Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting)
Fluent in written and verbal English
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
United States of America - $50,000.00 - $99,000.00
The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
We love knowing that someone is going to have a better life because of the work we do.
Worldwide Clinical Trials (Worldwide) is a global CRO serving development-driven biopharmaceutical companies, with more than 4,400 professionals operating across more than 70 countries. The company delivers therapeutically dedicated expertise in neuroscience, oncology, rare disease, and internal medicine, with comprehensive support across every development phase – from early-stage and first-in-human studies through Phase III registration trials.
The company's flexible service model – spanning full-service trial management to functional service partnerships through Worldwide Flex – is powered by a people first, partnership driven outsourcing approach that strengthens collaboration, enhances data transparency, and supports more informed decision making. This provides sponsors with tailored, adaptable solutions that keep pace with the evolving demands of clinical research.
Learn more at www.worldwide.com
Offices: 600 Park Offices Drive, Suite 200, Research Triangle Park, NC 27709, US · 2455 Northeast Loop 410, Suite 150, San Antonio, TX 78217, US · 4509 Freidrich Lane, Building 2, Suite 200, Southpark Commerce Center Two, Austin, TX 78754, US · 245 First Street Riverview II, Suite 1847, Cambridge, MA 02142, US · 4.1 Manuel Ugarte 2110, CABA, Buenos Aires, 1428, AR
Neuroscience/Central Nervous System Clinical ResearchRare Disease Clinical ResearchOncology Clinical ResearchIMID Clinical ResearchCardiovascular and Metabolic Clinical ResearchCell and Gene TherapyGlobal & Local Regulatory SupportPhase I Clinical ResearchTrial OptimizationQuality Assurance
Worldwide Clinical Trials (Worldwide) is a global CRO serving development-driven biopharmaceutical companies, with more than 4,400 professionals operating across more than 70 countries. The company delivers therapeutically dedicated expertise in neuroscience, oncology, rare disease, and internal medicine, with comprehensive support across every development phase – from early-stage and first-in-human studies through Phase III registration trials.
The company's flexible service model – spanning full-service trial management to functional service partnerships through Worldwide Flex – is powered by a people first, partnership driven outsourcing approach that strengthens collaboration, enhances data transparency, and supports more informed decision making. This provides sponsors with tailored, adaptable solutions that keep pace with the evolving demands of clinical research.
Learn more at www.worldwide.com
Offices: 600 Park Offices Drive, Suite 200, Research Triangle Park, NC 27709, US · 2455 Northeast Loop 410, Suite 150, San Antonio, TX 78217, US · 4509 Freidrich Lane, Building 2, Suite 200, Southpark Commerce Center Two, Austin, TX 78754, US · 245 First Street Riverview II, Suite 1847, Cambridge, MA 02142, US · 4.1 Manuel Ugarte 2110, CABA, Buenos Aires, 1428, AR
Neuroscience/Central Nervous System Clinical ResearchRare Disease Clinical ResearchOncology Clinical ResearchIMID Clinical ResearchCardiovascular and Metabolic Clinical ResearchCell and Gene TherapyGlobal & Local Regulatory SupportPhase I Clinical ResearchTrial OptimizationQuality Assurance