The Senior Specialist, PV-O&GPE; collaborates with cross-functional colleagues to support operational regulatory pharmacovigilance (PV) company policies, processes, standards and software system configuration that impact individual case safety reports (ICSR), aggregate reports and downstream medical review and safety signaling activities. Maintains PV global standards for relevant activities to ensure compliance and quality aligned with SDLC (software development lifecycle), ICH/GCP and integral PV requirements. The Senior Specialist stays current on existing and emerging SDLC, ICH/GCP and PV regulations and guidance.
Core Responsibilities
- Develop and maintain the necessary processes and training to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations
- Participate in interdepartmental and cross-functional meetings to support operational and regulatory PV requirements and deliverable
- Maintain knowledge of PV regulations related to drugs, vaccines, biologics and devices.
- Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations
- Process incoming requests from internal and external sources related to PV requirements and assist in development of an appropriate course of action and/or response
- Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable
- Support integration of acquisitions, collaborations, and partnerships
- Collaborates with MRK IT to implement and manage system improvements and updates to the safety database and systems supporting PV activities
Key Responsibilities
- Participate and/or lead in the development of processes with internal and external stakeholders to ensure quality and compliance of individual case and aggregate safety reports
- Perform quality review of individual case and aggregate safety reports to ensur
📌 Sr. Spclst, Drug Safety (Bogotá)
🏢 Msd
📍 Bogotá
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