Safety Reporting Coord

hace 4 semanas

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We offer continued career advancement opportunities, award-winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:
Provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects. Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues.

May also be involved in updates to procedures and other initiatives related to safety reporting.

May mentor or train new central safety reporting staff.

Essential Functions:

- Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation.
- Assists in producing metrics and alerts manager to any quality or timeline issues.
- Ensures timely maintenance of safety reporting systems and information.
- Liaises with various departments and external parties (including clients) in relation to safety reporting tasks and the setting up and maintenance of projects.
- Good understanding of SOPs, GDs and project related documentation.
- Proactively troubleshoots daily operational issues with limited input from management.
- With support of management, provides updates to the operational safety reporting team and Senior Management in relation to work deliverables / status as required and in accordance to regulatory requirements.
- Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
- Responsible for training Pharmacovigilance department staff on the safety reporting process and various systems associated with safety reporting.
- Assists with, and may participate in, audit and inspection preparation if required or requested by the company or client.
- Knowledge of, and ability to perform against, critical metrics for projects. Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.

Education and Experience:

- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
- In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

- Ability to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks
- Ability to work effectively as an individual and independently to attain the wider goals of the team.
- Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint)
- Good knowledge of Pharmacovigilance and industry terminology
- Strong written and verbal communication skills, including telephone conversations as

  • Safety Reporting Coord

    hace 4 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Safety Reporting Coord

    hace 2 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Experienced Clinical Safety Coordinator

    hace 3 semanas

    Buenos Aires, Argentina Medpace, Inc. A tiempo completo

    Job Summary: Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team! This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an...

  • Safety Admin

    hace 5 días

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Associate Business Analyst

    hace 1 mes

    Buenos Aires, Argentina JPMorgan Chase & Co A tiempo completo

    **JOB DESCRIPTION** The DRR Team plays an integral role in the monthly, quarterly, and year end close processes. The DRR team works very closely with CIB Technology, LOB Controllers and P&A partners across the Finance organization. The DRR System provides critical downstream feeds to Market Risk which are used for p/l back testing and the Team and helps with...

  • Health, Safety and Environment Specialist

    hace 4 semanas

    Buenos Aires, Buenos Aires C.F., Argentina ABB A tiempo completo

    Health, Safety and Environment SpecialistTake your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future.At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together, we...

  • Pharmacovigilance Physician

    hace 4 semanas

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who...

  • Hseq Assistant

    hace 4 semanas

    Buenos Aires, Argentina Cummins A tiempo completo

    Provides administrative technical support for key health and safety initiatives coordinating data collection checking for accuracy, reporting through required HSE systems, maintaining records for occupational health and safety training and coordinating and assisting in meeting preparations. Maintains local health and safety policies and...

  • Hseq Assistant

    hace 4 semanas

    Buenos Aires, Argentina Cummins Inc. A tiempo completo

    **HSEQ Assistant** **Description** Provides administrative technical support for key health and safety initiatives coordinating data collection checking for accuracy, reporting through required HSE systems, maintaining records for occupational health and safety training and coordinating and assisting in meeting preparations. Maintains local health and...

  • Pharmacovigilance Physician

    hace 2 semanas

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Company DescriptionWe are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who...

  • Hseq Assistant

    hace 2 semanas

    Buenos Aires, Argentina Cummins A tiempo completo

    Provides administrative technical support for key health and safety initiatives coordinating data collection checking for accuracy, reporting through required HSE systems, maintaining records for occupational health and safety training and coordinating and assisting in meeting preparations.Maintains local health and safety policies and procedures.Maintains...

  • Pharmacovigilance Senior Analyst

    hace 2 semanas

    Capital Federal, Buenos Aires, Argentina Johnson & Johnson A tiempo completo

    Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...

  • Pharmacovigilance Senior Analyst

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina Johnson & Johnson A tiempo completo

    Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...

  • Chevron Argentina

    hace 7 días

    Buenos Aires, Argentina CHEVRON ARGENTINA SRL A tiempo completo

    **Responsibilities for this position may include but are not limited to**: - Work with various HSE team members to support environmental stewardship framework. - Support Chevron lower carbon initiatives and activities. - Support in the improvement of Green House Gas (GHG) reporting and data quality. - Support improving regulatory permitting workflow and...

  • Pharmacovigilance Specialist Pvs

    hace 3 semanas

    Buenos Aires, Argentina Caidya A tiempo completo

    **Job Title: Pharmacovigilance Specialist PVS** **Job Location**: Argentina (In or around the Buenos Aires area) **Job Overview**: The Pharmacovigilance Specialist (PVS) primary responsibility is SAE case management. This includes but is not limited to initial case disposition, confirmation of case disposition with Medical Monitor (MM)/Safety Physician PV...

  • Hse - Enviromental Intern

    hace 1 semana

    Buenos Aires, Argentina Chevron A tiempo completo

    Total Number of Openings 1 Responsibilities for this position may include but are not limited to: - Work with various HSE team members to support environmental stewardship framework. - Support Chevron lower carbon initiatives and activities. - Support in the improvement of Green House Gas (GHG) reporting and data quality. - Support improving regulatory...

  • Chevron Argentina

    hace 2 semanas

    Buenos Aires, Argentina CHEVRON ARGENTINA SRL A tiempo completo

    Responsibilities for this position may include but are not limited to:Work with various HSE team members to support environmental stewardship framework. Support Chevron lower carbon initiatives and activities. Support in the improvement of Green House Gas (GHG) reporting and data quality. Support improving regulatory permitting workflow and compliance....

  • Hse - Enviromental Intern

    hace 2 semanas

    Buenos Aires, Argentina Chevron A tiempo completo

    Total Number of Openings1Responsibilities for this position may include but are not limited to:Work with various HSE team members to support environmental stewardship framework. Support Chevron lower carbon initiatives and activities. Support in the improvement of Green House Gas (GHG) reporting and data quality. Support improving regulatory permitting...

  • Responsable HSE

    hace 4 semanas

    Buenos Aires, Argentina HITACHI ENERGY ARGENTINA S.A.U. A tiempo completo

    Description : Mission: Contribute to improving Health, Safety and Environment (HSE) performance and Corporate Responsibility in assigned geography. Support the business by applying in-depth knowledge to offer solutions and advice through delivery of Group-wide performance improvement programs and/or Group Audit Program. Responsibilities: ...

  • Clinical Research Associate I

    hace 2 semanas

    Buenos Aires, Argentina Labcorp A tiempo completo

    Must have a Bachelor's Degree (or equivalent) with - 4 years of relevant healthcare experience in the pharmaceutical industry or clinical research, including - 2 years of monitoring and site management experience. All aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites within...