Senior Pharmacovigilance Associate

hace 2 semanas


Ciudad de México ICON Plc A tiempo completo

Senior Pharmacovigilance Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Pharmacovigilance Associate to join our diverse and dynamic team.

Location:

- Mexico City, Mexico (Hybrid mode: 3 days at office, 2 days from home)

Responsibilities:

- Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures
- Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.
- Generates data listings from the safety database and assumes responsibility for accuracy of the data.
- Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files*
- Perform safety review of clinical and diagnostic data as part of case processing.
- Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
- Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER
- Support Qualified Person for Pharmacovigilance as required.
- Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
- Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate.
- Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable)
- Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings.
- Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
- Supports interim data analysis for DMC reviews.
- Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
- Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.
- Supports Safety Scientist in signal detection and risk management activities.
- Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
- Proposes solutions for procedural and technical issues.
- Supports audits and inspections as required for the assigned projects.
- Perform other activities as identified and requested by management including but not limited to:

- Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.

Your Profile for Senior Associates:

- Experience in Pharmaceutical/CRO environment
- At least 4 year of experience in the pharmacovigilance area
- Experience in Leading projects and/or multiple studies
- Excellent verbal and written communication skills
- Detail-oriented
- Fluent in written and verbal English
- Excellent organizational and time management skills
- Ability to work effectively independently and within a team environment and across global teams.

LI-FP1

LI-Hybrid

What ICON can offer you:

- Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
- In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
- Our benefits examples include:
- Various annual leave entitlements- A range of health insurance offerings to suit you and your family’s needs.- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.- Life assurance- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our

careers site

to read more about the benefits ICON offers.



  • Ciudad de México ICON Plc A tiempo completo

    Pharmacovigilance Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Pharmacovigilance Associate to join our...

  • Pharmacovigilance Expert

    hace 12 horas


    Ciudad de México, Ciudad de México ICON A tiempo completo

    About the Role:This is an exciting opportunity for a seasoned Senior Safety Scientist to join our team at ICON. As a key member of our pharmacovigilance team, you will be responsible for leading signal detection and product safety activities. Your expertise in pharmacovigilance and signal detection will enable you to manage safety risk and contribute to the...

  • Pharmacovigilance Lead

    hace 2 días


    Ciudad de México, Ciudad de México ICON A tiempo completo

    About the RoleThis is a senior-level position in our safety team, responsible for leading signal detection and product safety activities. The ideal candidate will have extensive experience in pharmacovigilance, with expertise in signal detection and management.Key ResponsibilitiesSignal Detection and Management: Create and contribute to signal detection and...


  • Ciudad de México ICON A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...


  • Ciudad de México, Ciudad de México Scalero, Inc A tiempo completo

    Job Description:We are looking for a senior Financial Associate to support our financial operations at Scalero, Inc.As a Financial Associate, you will be responsible for preparing financial reports, analyzing data, and providing insights to inform business decisions.You will also oversee employee payroll processes, manage client invoicing, and execute...


  • Ciudad de México Novo Nordisk A tiempo completo

    Patient Safety Senior Associate - GBS **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:Ciudad de México, Ciudad de México, MX - At Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to...


  • Ciudad de México, Ciudad de México ICON A tiempo completo

    About the OpportunityWe are seeking a highly experienced safety professional to join our team as a Senior Principal Safety Scientist. In this role, you will be responsible for leading signal detection and product safety activities, as well as reviewing emerging safety data and preparing periodic safety reports.Key ResponsibilitiesSignal Detection and...


  • Ecatepec de Morelos, México Productlife Group A tiempo completo

    Pharmacovigilance Team Lead (French Speaker) PLG is looking for a dedicated Case Specialist Team Lead/ LPPV to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.Responsibilities: Plans the workload.Assigns the tasks on a timely manner.Organizes the planning and monitoring of one...


  • Ciudad de México, Ciudad de México Icon Plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.**What you will be doing**:- Perform processing for all types of safety events, medical information...


  • Ciudad de México, Ciudad de México Ntt Data A tiempo completo

    **Req ID**: 302836We are currently seeking a Testing Engineering Senior Associate to join our team in México, Ciudad de México (MX-CMX), Mexico (MX).Flujo básico de pruebas.Conocimietos en: Postman, Consultas a BD, pruebas web, pruebas en APP android y IOS, pruebas API's, backend & Frontend, azure devops.Ingles mantenga una conversación, B1 y...


  • Ciudad de México, Ciudad de México PER, Private Equity Recruitment A tiempo completo

    OverviewWe partner with leading companies in the private equity and alternative investment sectors. Our clients seek experienced professionals to join their teams. We are currently looking for a talented Senior Associate to support our clients' efforts in the renewable energy space.Job DescriptionDevelop and execute strategies for identifying and evaluating...


  • Ciudad de México, Ciudad de México DoorDash A tiempo completo

    Senior Associate, Finance & Strategy - Gross FeesWe're looking to expand our Finance & Strategy team in Mexico City (Remote). Our Finance team accelerates the growth of our business by implementing new opportunities and solutions. We partner with teams across the company to improve the profitability, scalability, and defensibility of our business model....


  • Ciudad de México, Ciudad de México Ntt Data A tiempo completo

    **Req ID**: 314082We are currently seeking a Testing Engineering Senior Associate to join our team in Mexico, México (MX-MEX), Mexico (MX)."- Minimum 3 years of QA testing experience.- At least 3 years of Manual testing experience.- At least 3 years of exposure to Agile software development methodology and Scrum implementation.- At least 3 years of...


  • Ciudad de México, Ciudad de México Ntt Data A tiempo completo

    **Req ID**: 314285We are currently seeking a Testing Engineering Senior Associate to join our team in Mexico, Ciudad de México (MX-CMX), Mexico (MX)."- Minimum 3 years of QA testing experience.- At least 3 years of Manual testing experience.- At least 3 years of exposure to Agile software development methodology and Scrum implementation.- At least 3 years...


  • Ciudad de México Warner Bros Careers A tiempo completo

    **_Every great story has a new beginning, and yours starts here._** **_ Welcome to Warner Bros. Discoverythe stuff dreams are made of._** **Who We Are ** When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD’s vast portfolio of...


  • Ciudad de México, Ciudad de México Kroll A tiempo completo

    Kroll is a global leader in risk and financial advisory solutions, providing trusted expertise and cutting-edge technology to navigate and redefine industry complexities. As a Senior Associate, you will be part of a collaborative and empowering environment that drives business growth and profitability.We are seeking a talented individual to join our Energy &...

  • Senior Legal Associate

    hace 3 semanas


    Ciudad de México, Ciudad de México Cloud4e A tiempo completo

    Get AI-powered advice on this job and more exclusive features. China Three Gorges Latam , a leading renewable energy company, is seeking a Senior Legal Associate to join the Mexico City team. The Senior Legal Associate for Mexico will oversee internal legal services for Kinich Energía (the "Company ") and the company's affiliates, providing comprehensive...


  • Ciudad Apodaca, Nuevo León, México Equinix A tiempo completo

    Senior Facilities Associates play a key role in maintaining the smooth operation of Equinix's data centers.As a Senior Facilities Associate, you will work closely with the operations team to deliver best-in-class service to our data center customers.Facility / Infrastructure MaintenanceThis includes performing specialized preventative and corrective...


  • Ecatepec de Morelos, México Eversanatm Company A tiempo completo

    Senior Medical Writer (Pharmacovigilance aggregate reports) - Homebased in Europe Full-time Department: Medical Writing We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008.We are proud to have achieved global organic growth year after year, with staff based across Europe, North America...

  • Patient Safety Associate

    hace 3 semanas


    Ciudad de México Novo Nordisk A tiempo completo

    Patient Safety Associate - GBS **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:Ciudad de México, Ciudad de México, MX - At Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create...