Global Pharmacovigilance Specialist
hace 2 semanas
Opportunity Overview
This role is situated within the Established Pharmaceuticals division at Abbott, focusing on enhancing the safety of our pharmaceutical offerings.
Our mission is to extend the reach of our trusted medications to a broader audience in rapidly developing markets. We maintain a diverse portfolio of high-quality branded generic medicines that span various therapeutic areas, including gastroenterology, women's health, cardiometabolic conditions, pain management, and respiratory health.
As a Global Pharmacovigilance Specialist, your primary responsibility will be to provide expert guidance and oversight for pharmacovigilance initiatives.
Key Responsibilities:
- Act as the representative of Abbott in communications with regulatory bodies regarding pharmacovigilance matters.
- Formulate strategic risk management frameworks for designated products.
- Evaluate clinical study protocols, reports, and related publications.
- Stay informed about regulatory standards, trends, and requirements relevant to products and clinical trials.
- Offer safety expertise throughout all phases of global drug development.
- Generate and assess safety documentation for reports submitted to regulatory agencies.
- Oversee the safety monitoring strategy, including individual case safety reports (ICSR), aggregate data analysis, and literature reviews, to mitigate risks to patients and products.
- Conduct medical evaluations during the processing of solicited cases.
- Perform health hazard assessments (HHAs) and quality management evaluations (QMES) as requested by quality assurance.
Position Scope and Accountability:
- Collaborate across various functions to support internal stakeholders, particularly the Qualified Person for Pharmacovigilance (QPPV) and affiliate safety representatives.
- Align pharmacovigilance strategies and maintain communication with external stakeholders.
- Foster transparency by engaging with teams in Regulatory Affairs, Clinical Development, and Medical Affairs, among other functional areas.
- Operate on a global scale, overseeing all countries with product registrations, primarily within a specific therapeutic area.
- Work autonomously while also seeking guidance when necessary.
- Provide support and input for assigned projects.
Required Qualifications:
- Doctor of Medicine (MD) or Doctor of Pharmacy (PhD).
Preferred Qualifications:
- A minimum of 8-10 years of experience in pharmacovigilance, medical affairs, or clinical development.
- At least 5 years of experience in pharmacovigilance safety assessments.
- Comprehensive understanding and experience in pharmacovigilance within the pharmaceutical industry or academia.
- Proven ability to operate in an international context and collaborate across various functional areas.
- Strong negotiation skills, tact, and diplomacy, along with advanced knowledge of standard business practices, including project management.
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