Safety & PV Submission Spec II - Experience with safety submissions for clinical

Safety & PV Submission Spec II - Experience with safety submissions for clinical trials in LATAM - Brazil Home BasedSyneos 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

Performs safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases 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 includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ISCR 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 Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.

Responsibilities:

• Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.

• May assist in the preparation of the project plans such as Safety Management Plan.

• May perform set-up, delivery and close-out of safety and pharmacovigilance projects.

• Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.

• 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.

• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.

• Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.

• Maintains safety tracking for assigned activities.

• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and 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.

• Quality review for the work performed by peers.

• Serves as a subject matter expert in SPVG, which includes resolution of project related routine queries; mentoring, coaching, and training of new hires.

• Fosters constructive and professional working relationships with all project team members, internal and external.

• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.

• Participate in audits/inspections as 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 and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.

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.

• Minimal travel may be required (up to 5%).

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.

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.

Originally posted on Himalayas