Sr Safety & PV Specialist. Madrid
- Hybrid
- Oversight of the Pharmacovigilance SystemsSyneos 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.
Why Syneos HealthWe 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.
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.
Get 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. http://www.syneoshealth.comJOB SUMMARYPerforms 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 ICSR, 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 minimal 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 RESPONSIBILITIESCoordinates 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

📌 Sr Safety (Madrid)
🏢 3212 Syneos Health Clinical Spain, S.L.U.
📍 Madrid