Pharmacovigilance Associate

hace 3 semanas

Ciudad de México CDMX Icon plc A tiempo completo

Pharmacovigilance Associate - Mexico, Mexico City

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 diverse and dynamic team.

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:

- Experience in Pharmaceutical/CRO environment
- At least 1 year of experience in the pharmacovigilance area
- 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.

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.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour

  • Pharmacovigilance Associate

    hace 7 días

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

    About the RoleAt Icon Plc, we are seeking a highly skilled Pharmacovigilance Associate to join our team. As a key member of our safety reporting team, you will be responsible for processing and reporting safety information for our clients.Key ResponsibilitiesProcess and reconcile safety events, medical information call handling activities, and other...

  • Pharmacovigilance Associate/Senior Associate

    hace 7 días

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

    Job SummaryWe are seeking a highly skilled Pharmacovigilance Associate to join our team at ICON Plc. As a Pharmacovigilance Associate, you will play a critical role in ensuring the safety of our clients' products by reviewing and processing safety events, generating data listings, and performing adverse event follow-up.Key ResponsibilitiesReview and process...

  • Pharmacovigilance Associate

    hace 7 días

    Ciudad de México, Ciudad de México Teva Pharmaceuticals A tiempo completo

    About the OpportunityWe are seeking a highly skilled Pharmacovigilance Associate to join our team at Teva Pharmaceuticals. As a key member of our Pharmacovigilance team, you will play a critical role in ensuring the safety of our products and maintaining compliance with regulatory requirements.Your Experience and QualificationsTo be successful in this role,...

  • Senior Pharmacovigilance Reporting Specialist

    hace 6 días

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

    Job Summary:As a Senior Pharmacovigilance Reporting Associate at ICON plc, you will play a critical role in ensuring the quality and integrity of pharmacovigilance reports. This position requires a strong understanding of pharmacovigilance regulations and guidelines, as well as excellent analytical and communication skills.About ICON plc:ICON plc is a...

  • Graduate Pharmacovigilance Associate

    hace 1 semana

    Ciudad de México, CDMX ICON A tiempo completo

    As a Graduate Pharmacovigilance Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory...

  • Pharmacovigilance Associate

    hace 7 días

    Ciudad de México, Ciudad de México IQVIA Argentina A tiempo completo

    Job OverviewThis role involves reviewing and processing safety data from various sources in accordance with applicable regulations, SOPs, and guidelines, ensuring compliance with industry standards and company policies.Key ResponsibilitiesComplete assigned trainings and certifications to stay up-to-date with regulatory requirements and industry best...

  • Senior Pharmacovigilance Associate

    hace 4 meses

    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,...

  • Senior Pharmacovigilance Associate

    hace 3 meses

    Ciudad de México ICON plc 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,...

  • Senior Pharmacovigilance Reporting Specialist

    hace 7 días

    Ciudad de México, Ciudad de México Icon plc A tiempo completo

    Senior Pharmacovigilance Reporting Associate - Mexico, Mexico CityICON 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 ICON can offer you:Our success...

  • Senior Pharmacovigilance Reporting Specialist

    hace 7 días

    Valle de Chalco Solidaridad, México ICON A tiempo completo

    Job SummaryAs a Senior Pharmacovigilance Reporting Specialist at ICON, you will play a critical role in ensuring the timely and accurate submission of safety reports to regulatory authorities, clients, and investigators. Your expertise in pharmacovigilance and safety reporting will be instrumental in maintaining the highest standards of quality and...

  • Patient Safety Senior Associate

    hace 4 semanas

    Ciudad de México, CDMX Novo Nordisk A tiempo completo

    Patient Safety Senior Associate - GBS Mexico **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...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    At Novo Nordisk, we are proactive in driving change and fostering an inclusive workplace that values diversity. We are seeking a Senior Associate in Patient Safety to become a vital part of our Clinical, Medical & Regulatory division. This role is ideal for individuals who possess meticulous attention to detail, excellent communication abilities, and a...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    At Novo Nordisk, we are proactive in driving change within the healthcare landscape. Our commitment to fostering an inclusive and diverse workplace is paramount, as we strive to build teams that reflect these values. We are seeking a Senior Associate in Patient Safety to become a vital part of our Clinical, Medical & Regulatory division. If you possess a...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    At Novo Nordisk, we are proactive in driving change within the healthcare landscape. Our commitment to fostering an inclusive workplace is unwavering, and we strive to create diverse teams that reflect our values. We are seeking a Senior Associate in Patient Safety to enhance our Clinical, Medical & Regulatory division at Novo Nordisk. If you possess...

  • Patient Safety Senior Associate

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

    About the RoleAs a Patient Safety Senior Associate at Novo Nordisk, you will play a critical role in ensuring the safety and efficacy of our products. Your primary responsibilities will include:Receipt, documentation, and quality assessment of inbound safety information, including adverse events and technical complaints.Ensuring compliance with all internal...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

    About Novo NordiskNovo Nordisk is a prominent global healthcare organization dedicated to combating serious chronic diseases. With a century-long legacy, we are expanding our reach and commitment to improving the lives of millions worldwide.Position OverviewWe are seeking a Senior Associate in Patient Safety to become a vital part of our Clinical, Medical &...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

    Position OverviewAs a Senior Associate in Patient Safety at Novo Nordisk, your primary responsibilities will include the reception, documentation, triage, and quality evaluation of incoming safety data, encompassing adverse events and technical complaints.You will also ensure adherence to all internal and external safety reporting obligations related to the...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

    Position OverviewAs a Senior Associate in Patient Safety at Novo Nordisk, you will play a crucial role in the management of incoming safety data, including adverse events and technical complaints. Your responsibilities will encompass the receipt, documentation, triage, and quality evaluation of this information.Additionally, you will ensure adherence to all...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

    Position OverviewAs a Senior Associate in Patient Safety at Novo Nordisk, your primary responsibilities will include the receipt, documentation, triage, and quality evaluation of incoming safety information, which encompasses adverse events and technical complaints.You will also ensure adherence to all internal and external drug and device safety reporting...

  • Senior Associate in Patient Safety

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

    About Novo NordiskNovo Nordisk is a global leader in healthcare, dedicated to combating serious chronic diseases. With a rich history spanning over a century, we are expanding our impact, reaching millions globally and improving the lives of over 40 million patients daily. Our success is driven by the collaboration and potential of our 64,000 employees...