Senior Specialist, Regulatory & PV Network
ERGOMEDRemotely
gcpproject managementpharmacovigilanceregulatorysopsauditsgvplcp
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Job Description
📋 Description
- Act as Local Contact Person for Pharmacovigilance for the designated country
- Lead regulatory deliverables and PV activities per plan across projects of varying complexity
- Develop strategies and manage setup activities (PM Plans, SOPs, POAs, core documents)
- Provide strategic input and mitigate risks with preventive actions
- Support budgeting, invoices, and vendor performance tracking
- Mentor junior staff and foster cross-functional relationships
🎯 Requirements
- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent
- Experience in pharmaceutical/CRO/regulatory environments
- Knowledge of ICH GCP and/or GVP and national regulations
- PV training or related experience; English proficiency; local language fluency
- Strong planning, organizational, and interpersonal skills
- Attention to detail in fast-paced, deadline-driven settings
🎁 Benefits
- Quality-focused culture with integrity and trust
- Drive and passion for patient safety
- Agility and belonging within a collaborative team
- Global reach and opportunities for growth
- Supportive environment for professional development