
Pharmacovigilance Operations Manager
1 dia atrás
About the Role:
- Evaluate and manage pharmacovigilance procedures to ensure compliance with international regulations.
- Respond promptly to health authority requests regarding safety information.
- Manage post-marketing surveillance activities, submitting adverse event reports to global pharmacovigilance teams.
- Develop and review pharmacovigilance procedures specific to Latin America, aligning with current regulations and good practices.
- Provide training for employees on pharmacovigilance best practices.
- Prepare and review periodic pharmacovigilance reports, analyzing key performance indicators.
- Report adverse drug reactions to Latin American health authorities, ensuring timely documentation.
- Maintain accurate pharmacovigilance documentation in accordance with industry standards.
- Collaborate with regulatory bodies and stakeholders to achieve shared goals.
- Optimize pharmacovigilance processes to improve quality and efficiency.
Requirements:
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Proficiency in English and Spanish languages.
- 5-7 years of experience in pharmacovigilance field.
- In-depth knowledge of pharmacovigilance legislation and industry standards.
Key Responsibilities:
This role is responsible for overseeing pharmacovigilance operations, ensuring adherence to regulatory guidelines. The successful candidate will be a seasoned professional with expertise in pharmacovigilance principles, regulations, and best practices.
As a Pharmacovigilance Specialist, you will play a critical role in maintaining the highest level of patient safety while ensuring business growth through effective risk management strategies.
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