Safety Specialist - Mexico - with fluent portuguese

Syneos Health, Inc.; México; Hybride; MXN 420 000 - 620 000; Plein temps

Résumé du poste

Syneos Health is seeking a Safety Specialist for Mexico to support regulatory safety activities, including ICSR processing, data coding, and timely reporting of adverse events.

The role requires a life science degree, experience with safety databases and MedDRA coding, and strong communication skills. You will work within cross-functional teams to ensure compliance with global pharmacovigilance regulations.

Qualifications

• Bachelor’s Degree in life science, nursing, or pharmacy.
• Safety database systems and medical terminology knowledge.
• Understanding of clinical trial processes and pharmacovigilance.
• Proficiency with Microsoft Office Suite and basic IT tools.
• Strong written and verbal communication skills.

Responsabilités

• Enter information into PVG quality tracking systems for ICSR receipt and tracking.
• Triages ICSRs and evaluates data for completeness and regulatory reporting.
• Enter data into safety databases and perform MedDRA coding when needed.
• Assist in reporting expedited safety information in compliance with regulations.
• Maintain safety tracking for assigned activities and support TMF submissions.
• Participate in audits and ensure SOP/ICH/GVP compliance.

Description du poste

Safety Specialist - Mexico - with fluent portugueseSyneos 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.Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.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*** Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs 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 testsCompiles 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 ICSRs.* Identification and management of duplicate ICSRs.* Activities related to SPOR / IDMP.* Quality review of ICSRs.* 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.