Drug Safety Specialist

4 weeks ago

Metro Manila, Philippines Sysgen RPO, Inc. Full time

Remote job (until further notice)
Mid shift - 2 pm PH time
Direct-hire
Equipment provided

Primary Responsibilities 

 DSS is primarily responsible for 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 stake holders. 

 Handling of safety mailbox through email and/ or tools. 

 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/ inspections and for Deviation/ Corrective Actions and Preventive Actions (CAPA) management. 

 Ensure up to date all the relevant trackers and /or formats. 

 Maintain a high standard of case quality. 

 Assisting with reconciliation of all adverse event reports received from customers and its affiliates. 

 Management and prioritization of individual workload while maintaining good documentation practices (GDP). 

 Handling and management of Eudravigilance and health authority reports. 

 Contribute to the development of SOPs and PV training including updates and implementations. 

 Highlighting any safety related issues to the attention of the management team. 

 All other ad hoc PV activities as required by the business needs. 

 Keep abreast of changes to PV Legislation. 

 Adhere to agreed Key Performance Indicators (KPIs).
 

Qualification (i.e., preferred education, experience) 

 Pharm D/ Post Graduation in Pharmacy or equivalent 

 3+ years of relevant experience
 

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