FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
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, with a strong understanding of international regulations and the ability to manage safety data effectively. Proficient in the preparation and submission of regulatory safety documents and aggregate safety reports.
Highest-signal resume keywords
Pharmacovigilance ExperienceKnowledge of ICH and EU GVP RegulationsExperience with PV DatabasesFluent English LanguageAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacovigilanceClinical SafetySafety Data ReconciliationNarrative WritingRegulatory Document SubmissionMedDRA CodingProject ManagementData ManagementQuality ReviewSignal Detection
Soft Skills
Time ManagementProblem-SolvingCollaborationAttention to DetailCommunication
Tools & Technologies
Veeva Vault SafetyArgusArisGSafety DatabaseIT Systems
Industry Keywords
Serious Adverse EventPeriodic Safety Update ReportsRisk Management PlansClinical TrialsCRO Experience
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Responsible for processing of ICSRs, Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, narrative writing, requesting follow-up from site, quality checks/review and reporting to client (s) or agencies for assigned projects)
- Perform reconciliation of safety data
- Participate in Project / Study Team meetings as the Safety and Pharmacovigilance representative
- Oversee the planning, coordination, and quality review of aggregate safety reports, support the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL).
- Supervision of local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans and risk minimization activities
- Collaborate with medical, safety physicians, and data management, IT, other functions to ensure timely and accurate reporting or reports delivery
- Act as Biomapas and/or contractual partners 24/7 local contact person or back up for pharmacovigilance at local level
- Ensure the survey and monitoring of national / regional pharmacovigilance regulations
- Collection and processing of any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source
- Support of weekly monitoring of local or global literature review
- Support of continuous safety profile monitoring, detection of new signals and evaluation
- Participate in related inspection and/or audits, including post inspection/audit support, when required
Requirements
What you’ll need- University degree in the Life Science field
- At least 5+-year’s 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., Veeva Vault Safety, Argus, ArisG, etc) and MedDRA coding
- Strong computer literacy
- Ability to interpret and apply global drug safety regulations
- Fluent English language
- Eager to adopt automations and new technologies in daily tasks
- Attention to detail, time-management and problem-solving skills
- CRO experience is a plus
- Project management experience is a plus
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
- Rewarding referral policy
- Workplace establishment allowance (fully remote)
- Team building, global meetings, B active events