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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs and pharmacovigilance, with a strong focus on compliance, safety reporting, and clinical trial submissions. Proven leadership in managing teams and ensuring inspection readiness in a regulated environment.
Highest-signal resume keywords
Regulatory SubmissionsPharmacovigilanceEudraVigilanceICH-GCPGVP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsSafety ReportingSignal DetectionMedDRA CodingClinical Trial SubmissionsPSMF ManagementRMP Management
Soft Skills
Analytical ApproachClient-FocusedExcellent Communication
Industry Keywords
EU CTRFDA RegulationsSUSARsICSRsPSURsASRsSafety Management Plans
About the role
Key responsibilities & impact- Lead, develop, and support the RA/PV team
- Manage workloads and serve as the primary regulatory and safety contact for clients
- Oversee clinical trial submissions and communications with Regulatory Authorities and Ethics Committees
- Provide regulatory sign-off on key study documents
- Manage safety reporting, including SUSARs, ICSRs via EudraVigilance, PSURs, and ASRs
- Manage signal detection, safety databases, and Safety Management Plans
- Act as the EU or Local QPPV, or Deputy, where required
- Oversee the PSMF and RMP
- Ensure GVP compliance and inspection readiness
- Support business development and continuous process improvement
Requirements
What you’ll need- Degree in Pharmacy, Medicine, Life Sciences, or a related field
- Strong knowledge of ICH-GCP, the EU CTR, FDA regulations, and GVP
- Hands-on experience with regulatory submissions and pharmacovigilance
- Experience with EudraVigilance and MedDRA coding
- Experience with PSMFs and RMPs is an advantage
- Proven experience leading teams in a regulated environment
- Analytical, client-focused approach with excellent communication skills
- Fluency in English
Benefits
Comp & perks- Permanent employment
- Full-time employment
- Hybrid work arrangement
- Continuous process improvement opportunities