Safety & Pharmacovigilance Submissions Specialist I/II - Poland, Sponsor-dedicated

Description

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

Main responsibilities:

• Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.
• Develop training materials as needed and provide training and on-boarding to new hires, if required
• Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
• Manage content and functionality of databases and shared working space (e.g. CelAlert, Investigator Space, Country Requirements) in support of maintaining safety information for clinical trials
• Manage and triage inquiries received via centralized mailbox and mitigate user/system performance issues or escalate as necessary
• Review of national guidelines for EC reporting requirements, ensuring regulatory compliance with regards to safety reporting.
• Ensure consistency and accuracy of safety information and reporting requirements for EU and ROW through periodic checks to identify issues; resolves issues through data verification and reporting improvement efforts
• Reconcile information received and distributed
• Distribute relevant documentation to investigational sites, ECs, or vendors as per requirements and distribute communications and study documents to study teams.
• Create and manage training content for internal and external users, as appropriate
• Primary point of contact for business user community to provide day to day support of system(s) used to support process.
• Subject matter expert on use of clinical system/portal, functional capabilities and relevant business processes enabled by the system.
• Liaise with vendors as appropriate (e.g. portal platform, printing, translations)
• Contribute to development of procedural documents and continual process improvement
• Perform all other duties as assigned.
• Oversee and/or perform RCO- SDG tasks related to GCP (such as SUSAR, IB and ASR distribution, global translations
• Communicate with Trial Managers and Study Teams on progress of RCO-SDG activities pertaining to a particular study, where necessary
• Maintain oversight of TMF for related documents including routine QC.

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.