FSP Safety Reporting Specialist – Night Shift

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

📋 Description

• Oversee and coordinate the creation of regulatory and safety reports

• Ensure precise and timely documentation of adverse events

• Assist in maintaining compliance with global pharmacovigilance standards

• Receive, prepare, and submit safety reports to relevant parties

• Notify the lead and/or line manager if any issues arise

• Ensure that reports are submitted in accordance with regulatory deadlines and national legislation

• Aid in generating metrics and alert managers to any quality or timing concerns

• Engage in project teams and may lead projects of small to moderate scale

• Provide training and assistance to fellow team members

• Execute administrative duties such as filing and maintaining safety reporting systems and information

• Collaborate with various departments regarding safety reporting tasks and the establishment of client accounts

• Participate in audits as necessary and carry out testing activities as required

• Share insights and suggestions with team members to ensure effective communication and engage in process improvement initiatives.

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic/vocational qualification

• Prior experience providing the knowledge, skills, and abilities necessary for the role (equivalent to 2+ years)

• Strong understanding of medical terminology

• Excellent written and verbal communication abilities

• Proficient in Microsoft Word and Excel, with a solid understanding of safety database functionality

• Comprehensive knowledge of procedural documents and a working understanding of global safety reporting requirements (including FDA regulations and guidelines)

• Capability to manage multiple tasks while consistently delivering high-quality results

• Strong attention to detail and accuracy, with an emphasis on careful and meticulous work

• Maturity to handle sensitive information and data efficiently

• Ability to interact effectively with all levels of the organization

• Strong critical thinking and problem-solving abilities.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Professional development opportunities