Safety & PV Specialist - Future Roles (Mexico)

Syneos Health, Inc.; Ciudad de México; Híbrido; MXN 400.000 - 650.000; Jornada completa

Descripción de la vacante

A global healthcare solutions company is looking for a Safety & PV Specialist to join their team in Mexico City. This role involves managing safety tracking, reviewing literature for safety, and maintaining regulatory compliance. The ideal candidate should have a Bachelor's degree in life sciences or related fields and be proficient in safety database systems. Strong communication and organizational skills are essential. This position offers a hybrid work model, providing flexibility while contributing to important healthcare projects.

Formación

• Bachelor’s Degree in life science, registered nurse, pharmacist or equivalent.
• Knowledge of Safety Database systems and medical terminology.
• Good understanding of clinical trial processes and regulations.
• Proficiency in MS Office suite, Visio, Outlook and Team Share.
• Ability to work independently and in a team.
• Excellent communication, interpersonal and organizational skills.
• Detail oriented with high accuracy and deadline discipline.

Responsabilidades

• Enter information into PVG quality and tracking systems.
• Perform literature screening and review for safety.
• Quality review of ICSR entries.
• Assist in timely, consistent reporting of expedited reports per regulatory requirements.
• Maintain safety tracking for assigned activities.
• Perform literature screening and safety data reviews; maintain drug dictionary; MedDRA coding.
• Validate and submit xEVMPD product records with appropriate indication coding.
• Manual recoding of un-recoded product/substance terms from ICSRs.
• Identify and manage duplicate ICSR records; SPOR / IDMP activities.
• Quality review of ICSR; ensure TMF and Pharmacovigilance system files meet SOP/Sponsor requirements.

Conocimientos

Safety Database systems

Clinical trial knowledge

Microsoft Office Suite proficiency

Excellent communication skills

Organizational skills

Detail-oriented

Clinical trial process (Ph II-IV)

ICH GCP / GVP

MS Office (Word, Excel, PowerPoint)

Visio

Outlook

Team Share / collaboration tools

Educación

Bachelor’s Degree in life science, registered nurse, pharmacist or equivalent

Herramientas

Microsoft Office

Visio

Outlook

Team Share

Descripción del empleo

Safety & PV Specialist - Future Roles (Mexico)

Updated: Yesterday
Location: MEX-Mexico City-Hybrid

Job Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of IC SRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. 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. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, 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 IC SRs.
• Identification and management of duplicate IC SRs.
• Activities related to SPOR / IDMP.
• Quality review of IC SRs.
• 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.
• Fosters constructive and professional working relationships with all project team members, internal and external.
• Participates in audits as required/appropriate.
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Qualifications

• 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), Team Share (or another 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.

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.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: [e-mail] One of our staff members will work with you to provide alternate means to submit your application.