Safety & Pv Submission Spec Ii

**Description**

**Senior Safety & Pharmacovigilance Submissions 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**
- 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
- 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

**Qualifications**

**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.
- Experience in a clinical research organization preferred with a minimum of five (5) years' Safety and Pharmacovigilance experience required including safety submissions
- 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
- 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 enviro