Pharmacovigilance Specialist: Regulatory Compliance and Risk Management
hace 1 semana
We are seeking a seasoned Pharmacovigilance Associate to join our dynamic team at ICON plc, a world-leading healthcare intelligence and clinical research organization.
**Job Summary:**
The successful candidate will be responsible for reviewing and processing safety events, generating data listings from the safety database, and maintaining project files. They will also provide input on relevant safety tracking systems, perform safety reviews, and support the creation of post-marketing safety activities.
**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.
**What We Offer:**
ICON plc offers a competitive salary of $70,000 - $90,000 per annum, depending on experience, as well as a range of additional benefits. Our benefits include annual leave entitlements, health insurance offerings, retirement planning options, employee assistance programs, life assurance, and flexible optional benefits.
We are 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.
-
Risk Management and Compliance Specialist
hace 2 semanas
Xico, México Bank Of America A tiempo completoAt Bank of America, we foster a culture that enables our teammates to thrive. Our Responsible Growth strategy empowers us to deliver value for our clients, communities, and shareholders.We prioritize the well-being of our global teammates by offering competitive benefits that support their physical, emotional, and financial health. This includes flexibility...
-
Pharmacovigilance Expert with Regulatory Compliance
hace 2 semanas
Xico, México Icon Plc A tiempo completoAbout ICON PlcAt ICON Plc, we pride ourselves on being a world-leading healthcare intelligence and clinical research organization. Our diverse and dynamic team is dedicated to fostering an inclusive environment that drives innovation and excellence.Senior Pharmacovigilance Associate Role OverviewWe are seeking a highly skilled Senior Pharmacovigilance...
-
Compliance Risk Management Specialist
hace 1 mes
Xico, México Citi A tiempo completoCiti is seeking a Compliance Risk Management Specialist to serve as a senior compliance risk analyst for its Independent Compliance Risk Management's Compliance Testing team. The ideal candidate will assess compliance risks and controls implemented by Citi's first and second line of defense.Key Responsibilities:Develops, implements, and executes compliance...
-
Compliance Risk Management Specialist
hace 2 semanas
Xico, México Citi A tiempo completo**Job Summary**We are seeking a highly skilled Compliance Risk Management Specialist to join our team at Citi.**Responsibilities**The selected candidate will be responsible for the Regulation Inventory Enrichment and Obligation Drafting, focusing on the enrichment of new laws or any amendment.Key responsibilities will include subject matter expertise in...
-
Regulatory Compliance Specialist
hace 1 mes
Xico, México Citigroup Inc. A tiempo completoAbout the Role:We are seeking a seasoned Regulatory Compliance Specialist to join our team at Citigroup Inc. This is a critical role that requires a strong understanding of regulatory requirements and risk management principles.Job Description:The successful candidate will be responsible for managing regulatory exams, coordinating with supervisory agencies,...
-
Global Compliance and Risk Management Specialist
hace 2 semanas
Xico, México Ebury A tiempo completoAt Ebury, we're seeking a highly skilled Global Compliance and Risk Management Specialist to join our team. This exciting role offers the opportunity to make a real impact in shaping our company's future.About the RoleThis is a challenging position that requires exceptional attention to detail, strong analytical skills, and excellent communication abilities....
-
Regulatory Compliance Specialist
hace 4 semanas
Xico, México Citi A tiempo completoCiti is a leading financial institution seeking a highly skilled Regulatory Compliance Specialist to join our team. This role plays a critical part in ensuring the integrity of our operations and maintaining a strong compliance culture.We are looking for an experienced professional with a strong background in regulatory affairs, risk management, and internal...
-
EHS Regulatory Compliance Specialist
hace 1 mes
Xico, México Environmental Resources Management (Erm) A tiempo completoThe Environmental Resources Management (ERM) company is seeking an EHS Regulatory Compliance Specialist to join their team. This role will involve conducting research into environmental, health, and safety regulations in Latin America, finding and analyzing laws and regulations that apply in various countries, and identifying new, changed, and repealed laws...
-
Environmental Compliance Specialist
hace 1 mes
Xico, México Compliance Management International A tiempo completoJob SummaryWe are seeking a highly skilled Environmental Compliance Specialist to join our team in Mexico. As an EHS Auditor, you will play a critical role in ensuring compliance with regulatory requirements and industry standards.Responsibilities:Conduct EHS compliance audits in Mexico, identifying areas of non-compliance and providing recommendations for...
-
Regulatory Compliance Officer
hace 1 mes
Xico, México Citi A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Compliance Officer to join our team at Citi. As a key member of our risk management group, you will be responsible for participating in the coordination and execution of regulatory exams, including franchise relevant regulatory reviews and other supervisory activities impacting businesses and control...
-
Pharmacovigilance Reporting Specialist
hace 2 semanas
Xico, México Engineeringuk A tiempo completoCompany Overview: ICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence, welcoming talented individuals to join our mission in shaping the future of clinical development.About the Role: As a Pharmacovigilance Reporting Specialist...
-
Pharmacovigilance Specialist
hace 1 mes
Xico, México Thermo Fisher Scientific A tiempo completoJob DescriptionOverview:We are seeking a skilled Pharmacovigilance Specialist to join our team at Thermo Fisher Scientific. As a key member of our pharmacovigilance department, you will be responsible for performing day-to-day PV activities in a highly regulated environment.Responsibilities:Perform day-to-day PV activities, including data entry, coding, and...
-
Compliance Risk Management Specialist
hace 2 semanas
Xico, México Citi A tiempo completoAbout CitiCiti is a leading global bank, serving consumers, corporations, governments, and institutions. We strive to make a positive impact on society by investing in the communities we serve.Job SummaryThis is a challenging role that requires a strong understanding of regulatory requirements and compliance risks. As a Senior Compliance Analyst, you will...
-
Compliance Risk Management Specialist
hace 2 semanas
Xico, México Citi A tiempo completoDiscover a challenging career opportunity as a Compliance Risk Management Specialist at Citi, where you will play a critical role in ensuring business compliance with laws, regulations, and policy requirements.The estimated salary for this position is between $85,000 to $120,000 per annum, depending on your level of experience and qualifications. Job...
-
Cybersecurity Specialist
hace 1 mes
Xico, México Kyndryl A tiempo completoAbout the RoleWe are seeking a highly skilled Cybersecurity Specialist to join our team at Kyndryl. As a key member of our security operations, you will play a critical role in ensuring the confidentiality, integrity, and availability of our customers' IT infrastructure.Key ResponsibilitiesAssess, predict, prevent, and manage risk to IT infrastructure and...
-
Compliance Governance and Risk Management Specialist
hace 4 semanas
Xico, México Mastercard A tiempo completo**Company Overview**At Mastercard, we connect and power a digital economy that benefits everyone, everywhere. Our mission is to make transactions safe, simple, smart, and accessible.**Job Summary**We are seeking a highly skilled Compliance Governance and Risk Management Specialist to join our team. This role will be responsible for coordinating and compiling...
-
Senior Compliance Officer
hace 4 semanas
Xico, México Hsbc A tiempo completoHsbc is seeking a highly skilled Senior Compliance Officer to join our Risk Management team.Job Overview:We are looking for an experienced professional to supervise on-going and scheduled audits/reviews and regulatory inspections. The ideal candidate will ensure all information requirements and pending doubts/comments from reviewer teams are properly...
-
Xico, México Citi A tiempo completoCiti is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our organization, you will play a critical role in implementing and monitoring regulatory reports, ensuring compliance with applicable laws, rules, and regulations.**Responsibilities:**Implement and monitor regulatory reports, providing timely and accurate...
-
Compliance and Regulatory Risk Manager
hace 1 mes
Xico, México Citi A tiempo completoWe are seeking a highly skilled Compliance and Regulatory Risk Manager to join our team at Citi. As a key member of our organization, you will play a critical role in ensuring that our compliance programs and policies are best-in-class and align with the company's strategic goals.Key Responsibilities:Designing, developing, and delivering comprehensive...
-
Senior Compliance Risk Management Specialist
hace 1 mes
Xico, México Citi A tiempo completoServing as a critical component of Independent Compliance Risk Management's Testing team, this role is responsible for assessing compliance risks and controls implemented by the first and second line of defense. Key responsibilities include performing risk assessments of Citi's compliance risks, conducting independent testing activities to evaluate...