Senior Safety & PV Specialist – Oversight of Pharmacovigilance Systems

Syneos Health

. Perform safety and pharmacovigilance program delivery activities, including collection, processing, and reporting of individual case safety reports (ICSRs) .

Posted 10/20/2026full-timeMadrid • SpainSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in safety and pharmacovigilance program delivery, including ICSR management, safety data validation, and regulatory compliance. Proficient in coordinating project workflows and mentoring team members while ensuring adherence to GCP, ICH guidelines, and safety reporting standards.

Highest-signal resume keywords

Safety Database SystemsICSR ManagementRegulatory ComplianceClinical Trial ProcessesMicrosoft Office Suite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceMedDRA CodingData ValidationSafety Data ManagementDrug CodingQuality ReviewProject ManagementSafety ReportingLiterature ScreeningData Entry

Soft Skills

Strong Communication SkillsOrganizational SkillsDetail-OrientedDecision-MakingTeam Collaboration

Tools & Technologies

Microsoft Office SuiteVisioOutlookTeamShareSPVG Quality Tracking Systems

Industry Keywords

GCPICH GuidelinesGVPSafety SubmissionsTrial Master FilePharmacovigilance System Master FilePost-Marketing SafetyClinical TrialsSPOR/IDMPMedical Terminology

About the role

Key responsibilities & impact

Perform safety and pharmacovigilance program delivery activities, including collection, processing, and reporting of individual case safety reports (ICSRs)
Conduct literature screening and review for safety, drug coding, drug dictionary maintenance, MedDRA coding, and safety data management
Clean and validate xEVMPD product dictionary data; manually recode substance/product terms
Manage duplicate ICSRs and perform quality review of ICSRs, SPOR/IDMP activities, substances, products, organisations, and referentials
Prepare expedited and periodic safety reports in accordance with regulatory requirements
Coordinate project workflow, team workload, deliverables, timelines, budgets, quality, and project risks/issues
Assist with project plans, including Safety Management Plans, and participate in internal project review meetings
Perform project setup, delivery, and close-out activities
Enter and track information in SPVG quality and safety tracking systems and safety databases
Triage ICSRs, assess completeness and accuracy, enter data, code events and medical information, write narratives, and resolve queries
Coordinate reconciliation of safety data between clinical and safety databases
Serve as a subject matter expert, resolve routine project queries, mentor and coach colleagues
Manage a small project team when required
Ensure distribution of required expedited and periodic reports to the Safety Submissions team when contracted
Train investigators on ICSR reporting and project team members on relevant activities
Participate in audits and inspections
Maintain required documentation in the Trial Master File and Pharmacovigilance System Master File
Apply SOPs, regulations, GCP, ICH guidelines, GVP, project plans, and regulatory intelligence to safety reporting activities

Requirements

What you’ll need

Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
Safety Database systems and knowledge of medical terminology
In-depth understanding of clinical trial processes across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, Outlook, TeamShare or other management/shared content/workspace tools, and internet
Ability to work independently and in a team environment
Strong written and spoken communication, presentation, and interpersonal skills
Strong organizational skills with ability to prioritize and work on multiple tasks and projects
Detail-oriented with a high degree of accuracy and ability to meet deadlines
Ability to make effective decisions
Minimal travel may be required (up to 10%)

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Minimal travel (up to 10%)