03 ago
|
Syneos Health
|
Tlalnepantla de Baz
03 ago
Syneos Health
Tlalnepantla de Baz
Updated: Today
Location: Tlalnepantla, MEX, Mexico
Job ID: -OTHLOC-7304
Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying years of experience and deep expertise to understand customer needs and shape solutions. Join us in a Functional Service Provider partnership or a Full‑Service environment to collaborate with passionate problem solvers and help our customers achieve their goals.
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 a total rewards program.
- We are committed to building an inclusive culture where you can authentically be yourself. Our purpose, “Driven to Deliver,” captures the passion of our colleagues to shape solutions that dramatically impact people’s lives.
- We continuously build the company we all want to work for and that our customers want to work with—bringing together smart colleagues worldwide to shape the future of healthcare.
Job Summary
Performs safety and pharmacovigilance program delivery activities, including collection, processing, and reporting of individual case safety reports (ICSRs); literature screening and review for safety; drug coding; maintenance of drug dictionaries; MedDRA coding; data management activities such as cleaning and validation; preparation of expedited and periodic safety reports; and adherence to data privacy guidelines, GCP, GVP, regulatory guidelines, and company procedures for clinical trials and post‑marketing safety programs.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSR as required.
- Assist in the preparation of project plans such as Safety Management Plan.
- Perform set‑up, delivery, and close‑out of safety and pharmacovigilance projects.
- Process ICSDs according to SOPs and project/program‑specific safety plans.
- Triage and evaluate internal ICSR data for completeness, accuracy, and regulatory reportability.
- Enter and code events, medical history, concomitant medications, and tests into the safety database.
- Compile complete narrative summaries.
- Assess information that requires querying and follow up until information is obtained and queries are satisfactorily resolved.
- Participate in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Coordinate with data management staff concerning reconciliation of safety data between the clinical and safety databases.
Company website:
Company Commitment & Legal Statements
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, and qualifications of incumbents may differ from those listed in the Job Description. The company, at its sole discretion, will determine what constitutes an equivalent to the qualifications described above. Nothing contained herein should be construed to create an employment contract. 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.
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📌 Safety & PV Specialist II - Mexico Hybrid (Tlalnepantla de Baz)
🏢 Syneos Health
📍 Tlalnepantla de Baz