Senior Patient Safety Specialist
Medical Affairs
Lagos – Nigeria
Our client, a leading global pharmaceutical company, is seeking a highly experienced Senior Specialist in Global Patient Safety. This role requires a deep understanding of pharmacovigilance (PV) activities, local and global safety regulations, and the ability to manage patient safety processes efficiently. You will be the key contact for internal and external stakeholders, ensuring compliance with regulatory requirements and contributing to the overall patient safety function.
Key Responsibilities:
- Manage patient safety activities and processes at the country level, ensuring compliance with local and global pharmacovigilance (PV) requirements.
- Oversee patient safety systems, databases, and projects, ensuring efficient day-to-day operations in compliance with regulatory standards.
- Provide leadership and oversight in managing audits, inspections, and cross-functional collaboration to meet patient safety requirements.
- Maintain up-to-date knowledge of local health authority regulations and ensure procedural documents related to patient safety are current.
- Lead the creation and implementation of local risk management plans and support regulatory submissions with cross-functional teams.
- Ensure timely submission of safety documents such as ICSR, PBRERs, DSURs, RMPs, and DHPCs to local health authorities.
- Act as a mentor to newly appointed patient safety staff and manage patient safety vendor relationships.
- Collaborate with regulatory, marketing, and medical teams to deliver patient safety requirements for business and regulatory needs.
- Support local and global patient safety projects, ensuring full compliance with GVP and internal processes.
- Provide cross-functional training and ensure local standard operating procedures are in place for audits and inspections.
- Manage compliance data monthly and support the audit and inspection process, addressing any identified gaps.
Education, Qualifications, Skills, and Experience:
- Expertise in Pharmacovigilance and Good Pharmacovigilance Practice (GVP).
- Strong knowledge of health authority regulations.
- Experience in cross-functional collaboration and vendor management.
- Proficient in data analysis and patient safety systems management.
- Effective problem-solving and critical thinking skills.
- Strong leadership and mentorship abilities.
If you are passionate about patient safety and have a proven track record in pharmacovigilance, this is a fantastic opportunity to join a dynamic team and make a significant impact. Apply today to become a key player in our client’s mission to improve patient outcomes globally.