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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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PharmacovigilanceClinical SafetySafety Data ReconciliationNarrative WritingRegulatory Document SubmissionMedDRA CodingProject ManagementData ManagementQuality ReviewSignal Detection
Soft Skills
Time ManagementProblem-SolvingCollaborationAttention to DetailCommunication