Job Description

Description

Sr Safety & Pharmacovigilance Submission Specialist
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

Essential Functions of the Job (Key responsibilities)

Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials. Completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions. Perform case processing (including case deactivations) and data gathering tasks within Argus Safety Database and other Incyte systems (i.e. EDC systems). Assist with literature review and article procurement as required. Perform retrospective quality review and document findings, and contribute to metric compilation Assist with business partner and other query management. Represent Pharmacovigilance on project teams. Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes. Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required. Train and mentor case processing staff. Assist with creating procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes. Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times. Other responsibilities, as required.

Qualifications (Minimal acceptable level of education, work experience, and competency)

Bachelor's degree in a science or healthcare related discipline (nursing/pharmacy preferred), or equivalent. Minimum of 4 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience. Proficiency using safety database systems (Argus experience preferred). Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices. Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point). Excellent ability to work effectively within a team environment. Advanced organizational, time management, and problem-solving skills. Ability to create and deliver presentations.

Excellent verbal and written communication skills.

Fluency in written and verbal English. Travel (domestic and global) 10% Ability to travel to office for monthly departmental meetings at assigned Incyte offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.

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 . 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

The Senior Drug Safety Associate will be responsible for processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials. The position will be responsible for leading case management lifecycle from receipt through case completion. The role will also be responsible to liaise with relevant parties (intradepartmental, external service provider/vendor or business partners) for related case processing tasks as required.