Sr. Safety Specialist

Updated: Today Location: Buenos Aires, B, Argentina Job ID: 25111103-OTHLOC-7310-2DH
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- Join our Talent Network Description Sr. Safety Specialist
- 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.
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- 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. Responsibilities:

Job Description
: JOB TITLE: Senior Safety & Pharmacovigilance Specialist SELECT ONE: Clinical Solutions JOB CODE:00089*
* REPORTS TO:Manager, Safety & Pharmacovigilance; or designee*
* JOB SUMMARY: Performs safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ICSR reports, management of duplicate ICSR cases, Quality review of ICSRs, Substances, Products, Organisations and Referentials (SPOR) / Identification of Medicinal Products (IDMP) activities)) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. Ensures that the project/program activities are completed in accordance with agreed timelines, allocated budgets and required quality standards. Responsible for providing delivery and expertise with mínimal oversight. Coordinates workflow to ensure delivery of project/program. Accountable to the Project Lead or Safety Program Delivery Manager at the project/program level and line manager for deliverables. May act as a mentor for less experienced associates. At a project level, may act as Safety Program Delivery Lead for local or regional studies. JOB RESPONSIBILITIES:
- Coordinates workflow to ensure delivery of project.
- May be responsible for distributing and monitoring team workload.
- Escalates issues with project deliverables, finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely manner.
- Provides support to manage safety and pharmacovigilance project risks/ issues as required.
- Understands financial measures, work orders, performance metrics (including quality parameters, monthly budget reports, and changes in scope) and project budgets.
- Assists in the preparation of project plans such as Safety Management Plan.
- Assists in the preparation and participates in internal project review meetings as required.
- May perform set-up, delivery, and close-out of safety and pharmacovigilance projects.
- Maintains safety tracking for assigned activities.
- May enter information into SPVG quality and tracking systems for receipt and tracking ICSR.
- May process ICSRs according to Standard Operating Procedures (SOPs) and project/program
- specific safety plans.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications, and tests.
- Compiles complete narrative summaries.
- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Participates in the generation