Safety & Pv Ops Spec - Regulatory Intelligence

**Description**

**Safety & PV Operations Specialist - Regulatory Intelligence experience required**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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 SUMMARY**:
**Provides support and oversight of SPVG Regulatory Intelligence operations and activities, supporting multiple areas within the Safety & Pharmacovigilance Business Unit (BU) ensuring that identification, assessment, and regular maintenance of SPVG RI Items and documents are performed properly. Support update of the Global Reporting Requirement trackers (GRRTs) as well as general maintenance to ensure timely completion Serves as the individual contributor for assigned tasks associated with regulatory intelligence activities.. Direct responsible for conducting assigned regulatory intelligence searches for specific countries and RI items in timely manner.**:
**JOB RESPONSIBILITIES**:

- General_
- Search and support on the review Regulatory Intelligence Item (RA websites, EMA, ICH, Pinksheet and Tarius, etc.) on an ongoing basis.
- Updates or maintains of the GRRTs as needed
- Conducts Annual Country searches for assigned countries, including liaising with relevant RA as needed, under the supervision of a senior staff,
- Ensure filing of RI sources to the SPVG Regulatory Intelligence Document Repository.
- Supports to coordinate SPVG Regulatory Intelligence’s Impact Assessment for assigned RI Item
- Attend bi-weekly SPVG RI Reporting Committee and any ad-hoc meetings as required.
- Participate on meetings to discuss RI topics.
- Support SPVG RI Team on preparation for monthly Safety Impact Committee (SIC) meeting, including follow-up with relevant personnel as needed.
- Supports SPVG RI Team on creation of monthly RI Newsletters and their uploading to LC.
- Monitor SPVG RI mailbox and answer queries as delegated.
- Supports client-specific RI deliverables as delegated.
- Quality & Compliance_
- Supports SPVG RI Team by providing controlled document support per development, revision, or review; provides support for development of department or client-specific documents to ensure regulatory compliance.
- Training_
- Supports the development, of the training materials (planned or ad hoc) for the SPVG RI Team. Support PV Academy training sessions on RIs (e.g., Training on GRRT).
- Proposals_
- Supports SPVG Pre-Award Team on RI Costing and Budgets for RI Tasks as delegated under the supervision of a senior SVPG RI staff

**Qualifications**

**What we’re looking for**
- Bachelor's degree in life science, registered nurse, pharmacist, computer science or technology related field (technical role) or equivalent combination of education and experience.
- Drug Safety and PV Regulation (Global and Local) background/experience.
- Good computer skills and knowledge of relational databases. Oracle Insight/Analytics/Data Mart, and Crystal Reports/Business Objects, SQL Plus experience preferred (technical role)
- Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.
- Ability to work independently and in a team environment
- Ability to successfully prioritize and work on multiple tasks and projects
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Strong organizational and documentation skills
- Detail orient