Ra / QA / Pv Executive [pharmaceutical / Mnc]
3 days ago
**The Role**:
Collaborating with a **Pharmaceutical MNC **with a pipeline across multiple therapeutic areas, I am currently looking for a **RA/QA/PV Executive **to join their team to manage their regulatory, quality and pharmacovigilance activities, ensuring compliance and quality of their products to support commercial success.
**Responsibilities**:
- Keep up-to-date with regulatory knowledge and frameworks, communicating with the global, regional and local functions to ensure compliance
- Handle pharmacovigilance activities such as, but not limited to, safety events management and reporting, literature review, risk management plans, conducting trainings and maintain QMS in accordance to global standards and local regulatory requirements
- Prepare dossiers for product registration to achieve timely approvals and lifecycle management via post-approval variations
- Manage product recalls and product complaints, liaising with the manufacturing as necessary until case closure
- Ensure vendors providing outsourced activities remains compliant with applicable local and global standards
**Requirements**:
- **1 - 3 years' experience **in regulatory affairs, pharmacovigilance and/or quality assurance in the pharmaceutical industry
- **Relevant Bachelor's Degree (e.g. Pharmacy, Life Science, Biomedical)**:
- **Pharmacist is an advantage**:
- Possess good organizational skills and able to multi-task effectively
- Excellent internal and external stakeholder management
- Independent and yet able to collaborate with cross functional teams
**Interested Applicants**:
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
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