
Manager of Product Safety and Compliance
Há 6 dias
We are looking for a highly skilled professional to fill the role of Pharmacovigilance Manager in our organization.
Main Responsibilities:
- As a key member of the Scientific Affairs Organization, you will be responsible for ensuring the safety of our products and compliance with regulatory requirements.
- You will serve as the local nominated contact for Pharmacovigilance (PV) and have oversight of all PV activities performed in Brazil.
- It is your responsibility to ensure that PV activities are managed in compliance with local regulations and company policies/procedures.
- You will participate in communication of PV topics with local Health Authority (ANVISA) and coordinate answers with Local, Regional PV and Global PV teams.
- One of your key responsibilities will be to drive and continuously improve compliance for products by proactively identifying compliance risk areas and managing the investigation of root causes contributing to the compliance issue.
- You will participate, contribute, and lead local, regional, and global projects related to pharmacovigilance.
- It is also your responsibility to ensure best practices and lessons learned are shared at Area, Region, and Global Level.
- You will collaborate with compliance groups and case management teams to ensure accurate oversight information is provided to senior stakeholders.
Essential Knowledge & Skills:
- You should have general knowledge on healthcare and safety.
- Knowledge in Medical/Health Sciences is required.
- You should also have knowledge of local/global legal requirements.
- Leadership and People Management skills are essential for this role.
- You should have proven leadership and management capability with the ability to simplify complex workflows and simultaneously manage critical issues.
Qualifications:
- A degree in life sciences is preferred.
- You should have a qualification in Medical/Health Sciences and/or proven equivalent experience in pharmacovigilance and safety issue management.
- Experience of leading a PV Team and performing the role of an LSO is necessary.
- At least 8 years' experience in the pharmaceutical industry, with at least 3 years' experience in a position of responsibility within Pharmacovigilance is required.
We are looking for a candidate who is passionate about Pharmacovigilance and has a strong background in leadership and people management. If you have the skills and qualifications necessary for this role, we encourage you to apply now.
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