Safety & PV Specialist I - Dalian at Syneos Health

Dalian, Liaoning, China -

Full Time

Start Date

Immediate

Expiry Date

09 Oct, 26

Salary

0.0

Posted On

11 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, ICSR Processing, MedDRA Coding, Safety Database Management, Medical Terminology, Literature Screening, xEVMPD Submission, GCP, GVP, ICH Guidelines, Microsoft Office Suite, TMF Documentation, English Proficiency, Clinical Trial Process, Case Triage, Regulatory Reporting

Industry

Biotechnology Research

Description

Safety & PV Specialist I - Dalian Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point 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 their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities 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 reportability. ○ 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 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. QUALIFICATION REQUIREMENTS • 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. • At least one year of experience in pharmacovigilance related projects. • Experience handling medical devices preferred, including product complaint identification, analysis, categorization, investigation support, and complaint handling activities. • Working proficiency in English, with the ability to read, understand, and communicate safety-related information. • 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. • Detail oriented with a high degree of accuracy and ability to meet deadlines. 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. http://www.syneoshealth.com 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. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Responsibilities

The specialist is responsible for processing Individual Case Safety Reports (ICSRs), including data entry, coding, and narrative summaries in safety databases. They also manage safety tracking, literature screening, and ensure compliance with global regulatory requirements and SOPs.