Senior Associate, Pharmacovigilance - Mexico/Brazil - Remote

Visa Hunt; México; A distancia; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a Senior Associate, Pharmacovigilance to manage SAE data and safety reporting for large studies. You will draft Safety Management Plans, review SAE data for accuracy, enter data into safety databases, and generate queries to resolve missing information.

Responsibilities include QC of SAEs, preparing regulatory safety submissions, and collaborating with global teams to ensure compliance with international guidelines.

Formación

• Excellent understanding of medical and scientific terminology and ADR assessment
• Excellent understanding of international regulations and reporting requirements
• Strong computer literacy and data extraction capability
• Excellent written and verbal communication skills
• Excellent organizational skills and ability to handle multiple priorities
• Ability to work independently in a matrix team environment

Responsabilidades

• Author Safety Management Plan for assigned studies
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and related tracking
• Generate queries for missing or unclear information and follow-up with sites
• Perform QC of SAEs processed by other PV Associates
• Generate regulatory reports and safety submissions as needed

Conocimientos

Medical terminology

Pharmacovigilance knowledge

Regulatory knowledge

Data extraction

Stakeholder communication

Organizational skills

Educación

Bachelor’s degree in a science-related field or nursing

Herramientas

MS Office (Excel, PowerPoint, Word)

Descripción del empleo

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 Senior Associate, Pharmacovigilance does 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. Independently serves as Lead PV Associate on large sized studies/programs that are moderate to complex in scope of work.

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

• Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements

• Excellent 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 organizational 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

Your experience

• Bachelor’s degree in a science-related field, or nursing, or equivalent

• Minimum of 5 years 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 organizational 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

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

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’re on a mission to hire the very best and 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.

Originally posted on Himalayas