Executive Search Firm Monroe Consulting Group Philippines is recruiting a Drug Safety Specialist on behalf of a multinational CRO company. The role will report to the Regional Head with mainly remote working setup (onsite will only be as needed). Work schedule is night shift, following US time zone.
Key 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).
- Handling, reconciliation and management of safety data exchange agreements (SDEA)/Pharmacovigilance agreements.
- Author, update and review the Pharmacovigilance system master file (PSMF) and its annexures as per the regulatory requirements.
- Compliance to be monitored as per SOPs.
- To support in the preparation of presentations and extracting line listings and delivering per business needs.
Qualifications:
- Bachelor's Degree in Nursing
- At least 2 years of experience in pharmacovigilance related activities specifically for clinical trials
- Solid project management skills with the ability to manage multiple projects simultaneously.
- Excellent oral and written communication skills including paraphrasing skills.
- Expertise in relevant therapeutic areas as required for processing Adverse events (AEs).
- Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately.
- Ability to maintain a positive and professional demeanor in challenging circumstances.
- Ability to work effectively within a team to attain a shared goal.
- Strong attention to detail.
- Advanced computer skills with the ability to work within multiple databases.
- Advanced skills in Microsoft Office products (including Outlook, Word, and Excel).
- Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations.
