Descripción de la vacante

Senior Safety & PV Operations Specialist (SPVG Regulatory Intelligence)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 EVERYWHEREWhy 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.Responsibilities:JOB SUMMARY:Provides support to the Safety and Pharmacovigilance organization by identifying, assessing, tracking, and maintaining worldwide regulatory requirements and trends related to end-toJOB RESPONSIBILITIES:
- Maintain knowledge of current and upcoming Pharmacovigilance Regulatory Requirements- Search and review new or updated PV Regulatory Requirements (RA websites, regional/integral organizations and publications etc.) on an ongoing basis to identify relevant information- Perform assessment to determine the impact of new or updates PV requirements.
- Update or maintain the Regulatory Intelligence System, as needed- Support with ensuring accuracy of tracked data by conducting peer review of updates/changes.
- Conduct country searches for assigned countries and topics, including liaising with relevant RA as needed to ensure proper documentation of these searches and requirements on SPVG RI documents repository.
- Lead SPVG Regulatory Intelligence’s Impact Assessment for assigned RI Item, coordinate input from functional SMEs and follow-up to completion.
- Attend meetings as required.
- Prepare summary documents related to recent new/updated PV Regulatory Requirements.
- Contributes, reviews and drafts information for training materials, RI proposal and RI quality & compliance.
- Disseminate updates to SPVG department and customers,



as required- Monitor SPVG RI mailbox and answer queries- Supports customer-specific RI deliverablesQUALIFICATION REQUIREMENTS- Bachelor's degree in life science, registered nurse, pharmacist, law or equivalent combination of education and experience.
- Experience in a clinical research organization preferred with a minimum of five (5) years' Safety and Pharmacovigilance experience across multiple roles.
- In depth understanding of clinical trial process across Phases II-IV and post-marketing safety requirements, ICH GCP, GVP and regulations related 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 oriented with a high degree of accuracy and ability to meet deadlines- Able to make effective decisionsGet to know Syneos HealthOver 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.Additional InformationTasks, duties, and responsibilities as listed in this 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.

📌 Senior Safety & Pv Operations Specialist (Spvg Regulatory Intelligence) (Buenos Aires)
🏢 Syneos - Clinical and Corporate - Prod
📍 Buenos Aires