Principal Consultant overseeing client relationships, commercial strategy, and delivery governance at CMSPI. Responsible for deepening executive relationships and ensuring high - quality delivery with a consulting mindset.
About the role
- Consultant in Pharmacovigilance and Medical Device Vigilance to support international projects for pharmaceutical and medical device companies. Contributing to ensuring compliance with safety regulations in a dynamic consulting environment.
Responsibilities
- Support clients in ensuring compliance with Pharmacovigilance and Medical Device vigilance regulations
- Contribute to the safety monitoring of medicinal products and medical devices throughout their lifecycle
- Work in a dynamic consulting environment, collaborating with multidisciplinary teams across different countries
- Support Post-Market Surveillance (PMS) activities according to EU MDR
- Preparation and review of PMS Reports, PSUR for Medical Devices
- Support in Pharmacovigilance System Master File (PSMF) preparation and maintenance
- Participate in regulatory gap assessments and process improvements
Requirements
- Degree in Life Sciences, Pharmacy, Biotechnology or related field
- 2–5 years of experience in Pharmacovigilance and/or Medical Device Vigilance / Post-Market Surveillance
- Knowledge of EU Good Pharmacovigilance Practices (GVP)
- Knowledge of EU Medical Device Regulation (MDR) vigilance requirements
- Experience with PMS / PSUR for Medical Devices
- Incident reporting
- Familiarity with EudraVigilance and/or EUDAMED is an asset
- Strong analytical and problem-solving skills
- Ability to work in an international consulting environment
- Good organizational and project management abilities
- Strong written communication skills
- Attention to detail and quality mindset
- Team player with a proactive attitude
Benefits
- Contribute to shaping the future of the Life Sciences industry by supporting innovative projects
- Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise
- Offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations
Job title
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