-
Justice Program Advisor
hace 1 semana
SGI Global, LLC Tlahuac, MéxicoSGI Global LLC is seeking fluent a Spanish speaking **Justice Program Advisor **to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work ...
-
Criminal Investigations and Analysis Advisor
hace 1 semana
SGI Global, LLC Tlahuac, MéxicoSGI Global LLC is seeking fluent a Spanish speaking **Criminal Investigations and Analysis Advisor** to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative supp ...
-
Specialised Financial Reporting Expert
hace 3 semanas
HSBC Tlahuac, México**Regulatory Reporting Head - Mex & LAM** · Regulatory reporting area is responsible for RWA calculations under local and PRA requirements for Mexico and oversight for LATAM countries (Argentina, Chile, Brazil and Uruguay), providing relevant insights to the stakeholders. · **Key ...
-
Police Program Analyst
hace 1 semana
SGI Global, LLC Tlahuac, MéxicoSGI Global LLC is seeking fluent a Spanish speaking **Police Program Analyst **to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work w ...
-
Principal, Business Transformation
hace 1 semana
Zendesk Tlahuac, MéxicoJob Description · Who we're looking for · The Principal, Business Transformation leads high-priority cross-functional strategic initiatives, owning end-to-end planning and execution through the full initiative lifecycle. This involves partnering with senior leaders across the org ...
-
Senior Associate, Site Operations
hace 1 semana
Capital One Tlahuac, MéxicoWeWork Reforma Latino , Mexico, Ciudad de Mexico, Ciudad de Mexico · Senior Associate, Site Operations · At Capital One, we dare to dream, disrupt and deliver a better way. Our goal is simple—bring ingenuity, simplicity and humanity to an industry ripe for change. In Global Workp ...
-
Sales Manager
hace 2 semanas
Tricon Energy Tlahuac, México**Overview** · Come discover why Tricon has been certified as a Great Place to Work The award is based entirely on what current employees say about their experience working at Tricon. Great Place to Work is the global authority on workplace culture, employee experience, and the l ...
-
Sr. Legal Counsel
hace 3 semanas
Bridgestone Mexico Tlahuac, MéxicoInformación de la Compañía: · **At Bridgestone, you are always Free to Be** · Our customers, communities and society are becoming ever more diverse, and a sustainably strong workforce must mirror this diversity. That is why we're committed to cultivate an even more inclusive cult ...
-
Field Tech Senior Representative
hace 3 semanas
NTT DATA Tlahuac, México**Req ID**: 281116 · We are currently seeking a Field Tech Senior Representative to join our team in Mexico City (Tlalpan Area - Benito Juarez), Ciudad de México (MX-CMX), Mexico (MX). · Field Tech Senior Representative · Responsible for the on-site integration of company and mul ...
-
Field Tech Senior Representative
hace 1 semana
NTT DATA Tlahuac, México**Req ID**: 281117 · We are currently seeking a Field Tech Senior Representative to join our team in Mexico City (Tlalpan Area - Benito Juarez), Ciudad de México (MX-CMX), Mexico (MX). · Field Tech Senior Representative · Responsible for the on-site integration of company and mul ...
-
Controller Jr. Manager Finance
hace 3 semanas
Bacardi-Martini Tlahuac, MéxicoPosted · 19-Apr-2024 · Job type · Full time · Country · Mexico · Location · Tultitlan, Mexico · Lead recruiter · Abril Lugo · Function · All Finance · Reporting Line · Finance Controller · On-site/Remote · On-site · Level of experience · Professional (Management) · Contract type ...
-
Scrum Master
hace 2 semanas
Capgemini Tlahuac, México**RH: Vicente Ramírez** · **Location**:CDMX · **Industry - Sector**:INS · **What you'll do?** · - The entire team shares in that ownership and accountability, with the scrum master only responsible for managing the process and moving the project toward completion. · **What you'll ...
-
Quality, Health, Safety, Environment,
hace 3 semanas
Tricon Energy Tlahuac, México**Overview / Descripción General** · **About Tricon**: With over 27 years in business, Tricon has grown to become an industry leader in the global trade and distribution of chemicals. Our purpose is to efficiently and sustainably connect the world with essential goods. We do this ...
-
Analista Senior
hace 2 semanas
HSBC Tlahuac, México-Job description · Please consider this job is only available in Spanish. · **Función principal**: · El objetivo principal de esta posición es el brindar soporte y desarrollar herramientas confiables que permitan generar análisis y comprender a detalle los resultados del Banco en ...
-
Chofer/guardia de Seguridad
hace 3 semanas
Marriott International, Inc Tlahuac, México**Job Number** · **Job Category** Loss Prevention & Security · **Location** Courtyard Mexico City Vallejo, Calzada Vallejo 1090, Mexico City, Mexico, Mexico VIEW ON MAP · **Schedule** Full-Time · **Located Remotely?** N · **Relocation?** N · **Position Type** Non-Management · ** ...
-
Officer-loss Prevention
hace 2 semanas
Marriott International, Inc Tlahuac, México**Job Number** · **Job Category** Loss Prevention & Security · **Location** Courtyard Mexico City Airport, Sinaloa 31 Penon de los Banos, Mexico City, Mexico, Mexico VIEW ON MAP · **Schedule** Full-Time · **Located Remotely?** N · **Relocation?** N · **Position Type** Non-Manage ...
-
Content & CRM Marketing Intern (Cdmx)
hace 2 semanas
Inner Circle Tlahuac, México**Content & CRM Marketing Intern (based in CDMX)**: · **_ Hybrid / 25 hours per week_** · **Job description**: · Are you a proactive and enthusiastic individual ready to make a significant impact? Do you have a passion for marketing, content creation, and design? If you're excite ...
-
Agente de Seguridad
hace 1 semana
Marriott International, Inc Tlahuac, México**Job Number** · **Job Category** Loss Prevention & Security · **Location** The Westin Santa Fe Mexico City, Javier Barros Sierra 540, Mexico City, Distrito Federal, Mexico VIEW ON MAP · **Schedule** Full-Time · **Located Remotely?** N · **Relocation?** N · **Position Type** Non ...
-
Guardia de Sucursal
hace 1 semana
CENTRAL STORE Tlahuac, México_**CENTRAL STORE**_ · Somos un modelo de venta de ropa en formato mayoreo con mas de 20 años de experiência en el mercado Retail en México, con principales marcas: Only, Vero Moda, Jack & Jones, H&M, Adidas, Reebok, Target, Street One, Energie, 90 Degree By Reflex, Factorie, Sono ...
-
Vendedor de Piso
hace 2 semanas
CENTRAL STORE Tlahuac, México_**CENTRAL STORE**_ · Somos un modelo de venta de ropa en formato mayoreo con mas de 20 años de experiência en el mercado Retail en México, con principales marcas: Only, Vero Moda, Jack & Jones, H&M, Adidas, Reebok, Target, Street One, Energie, 90 Degree By Reflex, Factorie, Sono ...
Safety & Pv Specialist Ii For Mexico Only - Xico, México - Grabjobs Mexico
Descripción
Safety & Pharmacovigilance Specialist II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with.Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Job responsibilities Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required. May assist in the preparation of the project plans such as Safety Management Plan. May perform set-up, delivery and close-out of safety and pharmacovigilance projects. Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications and tests. Compiles complete narrative summaries. Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of un-recoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Quality review for the work performed by peers.Serves as a subject matter expert in SPVG, which includes resolution of project related routine queries; mentoring, coaching and training of new hires.
Fosters constructive and professional working relationships with all project team members, internal and external. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
Participate in audits/inspections as required.Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
Qualifications What we're looking for Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
Safety Database systems and knowledge of medical terminology required.Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
Ability to work independently and in a team environment. Excellent communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. Detail oriented with a high degree of accuracy and ability to meet deadlines. Minimal travel may be required (up to 5%). Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Learn more about Syneos Health .Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
