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Senior Drug Safety Specialist (Sr DSS)

GLOBAL PACIFIC SUPPORT • New York, NY, United States • $200k - $250k / year • 3w ago

Primary Responsibilities

Department/ Function: Pharmacovigilance (PV)

Sr DSS is primarily responsible for the overall planning, co-ordination and delivery of pharmacovigilance services to customers.
Oversee and may perform day-to-day Pharmacovigilance (PVG) activities within a highly regulated environment and driven by stringent timelines.
Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.
Effectively collaborates with various parties such as: project team members, customers and third-party stakeholders.
Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement.
Mentor new joiners and provide refreshers to the team.
Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
Maintains medical understanding of applicable therapeutic area and disease states.
Participates in/lead departmental initiatives; serves as a subject matter expert in designated area.
Ensure compliance is met to Regulatory bodies, affiliates and partners in the stipulated timelines.
Monitoring of the company sponsored digital media as per the Standard Operating Procedures (SOPs).
Act as case owner for assigned Individual Case Safety Reports (ICSRs) to ensure accurate completion of data entry (DE), Quality review (QR) and regulatory reporting, in line with SOPs and legislations.
Ensure conduct of timely literature searches according to appropriate regulations and SOPs for purpose of ICSR identification and other safety information.
Ensure quality review performed and appropriate attempts of follow-ups to library for full text, author or publisher/translating agency and affiliates.
To ensure the adequate support is met during Audits and inspections.
Handling deviations and Corrective Action and Preventive Action (CAPA) management.
Ensure up to date all the relevant trackers and/or formats.
Maintain a high standard of case quality.

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