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Safety & PV Submission Specialist I

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

• Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documents

• Participates in project launch activities for safety reporting tasks

• Prepares Safety Reporting Plan for safety submissions only projects

• Maintain tracking of safety submissions

• Provides Sponsor/Customer with expedited and periodic safety report submission status updates, as required

• Provides support and advice on expedited and periodic safety report issues to project team/Sponsor as required

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

• File documents according to project specific requirements (electronically or in hard copy as applicable).

• Forward completed safety submission documents to clients and other relevant parties

• Acts as a point of contact for regulatory issues related to safety submissions

• May be responsible for distributing and monitoring team workload

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

• Assists in the preparation and participates in internal project review meetings as required

• Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs), related to submissions.

• Participates in audits as required/appropriate

• 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 an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.

What We're looking for:

• 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.

• Location - Gurugram/Hyderabad Hybrid

• Experience in a clinical research organization preferred with a minimum of 2 years' Safety and Pharmacovigilance experience required including safety submissions

• Experience in Safety Submissions to regulatoty authorities (Ideal) sites and Ethics committee

• TMF Filing and oversight 

• Thorough knowledge on PV guidelines, EMEA,FDA and India guidelines

• Safety Database systems experience and knowledge of medical terminology required  In depth 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), TeamShare (or other management/shared content/workspace) and internet.

• Ability to work independently and in a team environment

• Strong communication, presentation, interpersonal skills, both written and spoken

• Strong 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  Able to make effective decisions

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

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.