Senior Drug Safety Specialist

This is a fully remote position, open to applicants in Singapore.

📋 Description

• Execute and oversee safety service operations in accordance with relevant guidelines and regulations.

• Collaborate with internal teams and management to guarantee quality, compliance, and efficient safety service delivery.

• Support budget preparations, proposal evaluations, bid defense meetings, and business development documentation.

• Create standard operating procedures (SOPs), work instructions, activity descriptions, process enhancements, key performance indicators (KPIs), and quality/compliance monitoring protocols.

• Identify and implement systems, processes, and documentation that facilitate preclinical, clinical, and post-marketing safety projects.

• Engage with sponsors and clients to collect feedback and ensure superior quality in service delivery.

• Formulate project plans, safety management plans, work instructions, and project documentation.

• Organize and prepare safety regulatory submissions.

• Coordinate with study teams, investigators, site personnel, medical monitors, consultants, and vendors.

• Monitor project progress, compile metrics, and provide operational updates.

• Oversee resources, workload, project finances, expenses, change requests, invoicing, and resource utilization.

• Maintain safety reports, project documentation, trackers, training records, issue logs, risks, and corrective and preventive action (CAPA) documentation.

• Serve as the Safety Lead, lead for the Safety Reporting Group, or National Responsible Person for Pharmacovigilance.

• Process, assess, code, quality-review, and report safety events related to drugs, vaccines, cosmetics, and medical devices.

• Produce safety narratives, queries, periodic safety reports, aggregate reports, trend reports, field safety notices, and clinical evaluation reports.

• Reconcile safety and clinical databases and address any discrepancies.

• Conduct scientific and medical literature searches to uncover safety reports and pertinent information.

• Execute signal management, risk management, medical information management, and device vigilance tasks.

• Perform regulatory intelligence surveillance and evaluate impacts on safety processes.

• Maintain regulatory information, SOPs, training materials, project safety plans, manuals, and associated documentation.

• Complete mandatory training and facilitate learning and development initiatives.

• Participate in meetings, audits, inspections, and continuous improvement initiatives.

• Disseminate knowledge throughout the organization and advocate for workplace health and safety.

⛳️ Requirements

• A full-time undergraduate degree or higher in medical and health-related fields.

• A minimum of 2 years of pertinent drug safety experience.

• Comprehensive understanding of international regulations and guidelines pertaining to clinical trial safety management, post-marketing pharmacovigilance, and device vigilance.

• Extensive experience in creating Pharmacovigilance Standard Operating Procedures and Work Instructions.

• High proficiency in tasks related to Pharmacovigilance workflows.

• Practical experience utilizing Argus and/or ArisGlobal safety databases.

• Demonstrated leadership capabilities.

• Background in establishing market research standards, systems, processes, and applications for Pharmacovigilance activities.

• Thorough knowledge of medical terminology.

• In-depth understanding of Pharmacovigilance guidelines and regulatory reporting obligations.

• Relevant experience within a clinical research setting.

• Strong customer service orientation and responsiveness.

• Experience in mentoring and motivating team members.

• Prior experience networking with key stakeholders.

• Familiarity with medical device vigilance, including relevant technical, regulatory, and quality requirements.

• Exceptional communication and interpersonal abilities.

• Capability to work independently, in small teams, and with diverse stakeholders.

• Proficiency in technology, including Microsoft Office applications.

• Ability to balance strategic thinking with attention to detail and quality.

• Adaptability and flexibility in response to changing organizational priorities.

• Compliance with relevant regulations, guidelines, SOPs, project requirements, and designated systems.

• Capacity to adhere to Work Health & Safety legislation and organizational procedures.

🏝️ Benefits

• Competitive compensation with a customized salary and benefits package.

• Flexible hybrid or remote working arrangements based on location and role.

• Opportunities for learning and access to a global network of scientific leaders.

• Employee wellbeing programs and initiatives that support work-life balance, health, and team connectivity.

• Participation in global engagement surveys.

• Recognition programs.

• Team-building activities.

• Exposure to a variety of international projects and clients.