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Safety & PV Coordinator hybrid CDM Mexico
hace 4 horas
Description
Safety & PV Coordinator hybrid CDM Mexico
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
- Monitors and routes incoming information to the appropriate project if required.
- Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes if required.
- Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP if required.
- Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards if required.
- Ensures current conventions are followed when entering cases into the Safety database.
- May perform file creation, tracking, retention, and maintenance (paper and electronic).
- Manages the translation process for any source documents requiring translation if required.
- Performs or assist with query follow up process as instructed.
- Assists with submission processes as required.
- Assists with daily workflow reconciliation.
- Assists with literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, if required.
- Assists with narrative writing.
- Assists with coding events, medical history, concomitant medications, and tests.
- Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Validation of xEVMPD product records, including appropriate coding of indication terms using MedDRA, if required.
- Manual recoding of un-recoded product and substance terms arising from ICSRs if required.
- Identification and management of duplicate ICSRs if required.
- Activities related to SPOR / IDMP if 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 of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/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.
Get to know Syneos Health
Over 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.
Summary
Responsible for assisting with departmental or project deliverables associated with the preparation and the processing of Individual Case Safety Reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which include cleansing and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ICSR reports, management of duplicate ICSR cases, quality review of ICSRs, Substances, Products, Organizations and Referential (SPOR), Identification of Medicinal Products (IDMP) activities) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practices (GCP), regulatory guidelines, and company and project-specific procedures. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.
