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Area Safety Lead
3 semanas atrás
We are seeking a seasoned professional to lead our pharmacovigilance efforts in LATAM. As the Area Safety Lead, you will be responsible for providing strategic direction and oversight to ensure compliance with regulatory requirements.
Key Responsibilities:- Collaborate with Medical Directors to support Pharmacovigilance initiatives
- Mentor and coach Local Safety employees in LATAM to achieve business objectives
- Analyze PV workload trends and optimize resource allocation
- Foster a culture of compliance and engage with OCMS departmental activities
- BUILD and maintain relationships with LOCs to implement safety standards
- Assume the PV role as defined by national law/regulation
- Collaborate with QPPV offices as required
- Ensure implementation of regional and/or business strategies
- Establish collaboration with Case Management team
- Act as local PV contact person for PV audits and inspections
- Sponsor or lead PV related projects
- Contribute to metric development
- Remain up-to-date with IT developments in pharmacovigilance
- Ensure dissemination of PV regulations and guidelines
- Maintain oversight of company activities generating patient data
- Maintain LATAM compliance data and provide advice
- Degree qualified in life sciences
- Qualification in Medical/Health Sciences and/or experience in pharmacovigilance and safety issue management
- Expertise in safety regulations and R&D processes
- Leadership experience in a PV Team and performing the role of a Local Safety Officer
- Minimum 6 years' experience in the pharmaceutical industry with 4 years' experience in a position of responsibility within Pharmacovigilance
- Team leadership and people management experience
- Flexibility and virtual team experience
- Fluent communication skills in English and Spanish or Portuguese; fluency in the 2nd LATAM language is a plus
