Medical Safety Manager
Há 1 mês
Job Title: Medical Safety Manager
Biom?Rieux Bv is seeking a skilled Medical Safety Manager to join our team. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety and quality of our products.
Salary: $80,000 - $110,000 per annum (depending on experience)
Job Description
We are looking for an experienced Medical Safety Manager to oversee the day-to-day activities of our Pharmacovigilance department. The ideal candidate will have excellent communication and organizational skills, as well as the ability to work independently with minimal supervision.
The successful candidate will be responsible for:
- Managing adverse event case intake and follow-up activities in accordance with global pharmacovigilance procedures and country regulations;
- Ensuring compliance with department SOPs, company policies, and local legislation;
- Performing reconciliation activities for PV cases received from local operating units and contractual partners;
- Providing support for Patient Support Programs and Market Research vendor activities;
- Filing, storing, and archiving safety-related data and documentation;
- Supporting local PV audits and inspections, including readiness activities and CAPAs;
- Participating in training and development of local staff, distributors, vendors, and business partners;
- Coordinating with local business units to ensure timely implementation of Risk Minimization Measures and ARMMs.
To be successful in this role, you will need:
- A degree in a relevant field, such as pharmacy, medicine, or life sciences;
- At least 3 years of experience in pharmacovigilance, medical affairs, or a related field;
- Excellent communication and organizational skills;
- Ability to work independently with minimal supervision;
- Proficiency in English and proficiency in Spanish and Portuguese languages;
- Experience with PV systems and their associated Quality Management Systems;
- Knowledge of global pharmacovigilance procedures and country regulations.
We offer a competitive salary, benefits package, and opportunities for professional growth and development.
OthersThis is a challenging and rewarding opportunity to join a dynamic team and contribute to the success of Biom?Rieux Bv. If you are a motivated and experienced Medical Safety Manager, we encourage you to apply.
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