Associate Director, Pharmacovigilance
argenx
full-time
Posted on:
Location Type: Remote
Location: Belgium
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Job Level
About the role
- Serve as scientific expert and pharmacovigilance resource to external and internal partners
- Act as point of contact for pharmacovigilance in the assigned country/region
- Support the Head of Regional PV in the harmonization of processes across the regions
- Establish and maintain the applicable pharmacovigilance system specific to the country/region
- Promote increased awareness of and ensure compliance with pharmacovigilance obligations
- Participate in health authority interactions throughout the product life-cycle as needed
- Develop relationships with cross functional teams and with business partners as it relates to adverse event reporting and other pharmacovigilance activities
Requirements
- Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
- At least 8-13 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 7 years in pharmacovigilance/drug safety
- Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
- Knowledge of the drug development process, GXP quality and compliance requirements
- Fluency in written and spoken English
Benefits
- Health insurance
- Equal consideration for employment without discrimination
- Inclusive environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilanceadverse event reportingdrug safetyregulatory requirementsGVP guidancedrug development processGXP qualitycompliance requirements
Soft Skills
relationship buildingcommunicationcollaborationinterpersonal skills
Certifications
Master’s degreePharmDMD