FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacovigilance and clinical safety, ensuring compliance with international regulations and quality management systems. Proficient in safety data processing, reporting, and collaboration with cross-functional teams.
Highest-signal resume keywords
Pharmacovigilance ExperienceKnowledge Of International RegulationsExperience With PV DatabasesFluent In English And Local LanguageProject Management Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Data ProcessingQuality Management System ComplianceNarrative WritingData ReconciliationAggregate Safety Reports PreparationRegulatory Safety Document SubmissionMedDRA CodingSignal DetectionRisk Management PlansClinical Development Knowledge
Soft Skills
Attention To DetailTime ManagementProblem-Solving Skills
Tools & Technologies
ArgusArisG
Industry Keywords
Pharmacovigilance LegislationICHEU GVP ModulesFDAClinical TrialsSafety Database EntryPeriodic Safety Update ReportsRisk Minimization Activities
About the role
Key responsibilities & impact- Assure compliance with the Quality Management System
- Process ICSRs and Serious Adverse Events from clinical trials, including safety database entry, tracking, narrative writing, site follow-up requests, quality checks/review, and reporting to clients or agencies
- Perform reconciliation of safety data
- Participate in Project/Study Team meetings as the Safety and Pharmacovigilance representative
- Oversee planning, coordination, and quality review of aggregate safety reports
- Support preparation and submission of regulatory safety documents, including DSURs and 6MLL
- Supervise local handling, preparation, and submission of Periodic Safety Update Reports and Risk Management Plans and risk minimization activities
- Collaborate with medical, safety physicians, data management, IT, and other functions to ensure timely and accurate reporting or report delivery
- Act as Biomapas and/or contractual partners’ 24/7 local pharmacovigilance contact person or backup
- Monitor national and regional pharmacovigilance regulations
- Collect and process medical enquiries received through phone, email, fax, or other means
- Support weekly monitoring of local or global literature review
- Support continuous safety profile monitoring, detection of new signals, and evaluation
- Participate in inspections and audits, including post-inspection/audit support, when required
Requirements
What you’ll need- University degree in the Life Science field
- At least 4+-years’ experience in Pharmacovigilance, clinical safety and clinical development and expert knowledge of pharmacovigilance legislation
- Knowledge of international regulations (ICH, EU GVP Modules, FDA)
- Experience working with PV databases (e.g., Argus, ArisG) and MedDRA coding
- Ability to interpret and apply global drug safety regulations
- Fluent English and local country language
- Eager to adopt automations and new technologies in daily tasks
- Attention to detail, time-management and problem-solving skills
- Project management experience is beneficial
Benefits
Comp & perks- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Additional health insurance
- Remote/home based
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance (fully remote)
- Team building, global meetings, B active events