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Medical Information Lead
IQVIA · Oeiras
Descrição do cargo
About the role
We are seeking a Medical Information Lead to oversee safety data processing and pharmacovigilance activities across multiple service lines. The role combines case management, regulatory support, and mentorship of junior staff within a fast‑paced global environment.
Key responsibilities
- Process and manage safety cases, including adverse event intake, data entry, coding, narrative writing, quality review and follow‑up.
- Assess case reportability and support regulatory submissions within required timelines.
- Perform pharmacovigilance activities in line with SOPs, regulatory requirements and project‑specific guidelines.
- Support Safety Surveillance, Risk Management, Safety Publishing and Medical Information services as needed.
- Maintain high standards of quality, compliance, productivity and delivery.
- Provide training, mentoring and day‑to‑day support to less experienced team members.
- Monitor project progress, metrics and operational performance, escalating issues when required.
- Collaborate with project management, clinical, data management, investigators and clients to resolve project‑related issues.
- Contribute to process improvements, training initiatives and departmental goals.
- Participate in audits, inspections and continuous improvement activities.
- When required, perform medical review of non‑serious adverse events ensuring data quality and regulatory compliance.
Required profile
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Healthcare or a related scientific discipline.
- Up to 5 years of relevant experience, including up to 3 years in pharmacovigilance.
- Strong understanding of pharmacovigilance processes, case management and safety regulations.
- Excellent knowledge of medical terminology and safety databases.
- Strong organizational, time‑management and problem‑solving abilities.
- Effective written and verbal communication skills.
- Ability to manage multiple priorities while maintaining high accuracy and quality.
- Proven capability to work independently and collaboratively in a fast‑paced environment.
Required skills
- Microsoft Office
- Web‑based applications
- Pharmacovigilance databases
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Oeiras
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