Safety Reporting Specialist

Job Title: Safety Reporting Specialist Job Location: Remote, India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as Safety Reporting Specialist – To manage and coordinate the production of regulatory and safety reports, ensure accurate and timely documentation of adverse events, and support compliance with global pharmacovigilance requirements. What You’ll Do: Receive, prepare and submit safety reports to applicable parties. Escalate to lead and/or line manager if any issues are encountered. Ensure reports are submitted in compliance with regulatory timelines and country legislation. •Assist in producing metrics and alerts managers to any quality or timeline issues. •Participate in project teams and may lead projects of small to moderate scope. •Provide training and support for other team members. •Perform administrative tasks such as filing and the maintenance of safety reporting systems and information. •Liaise with various departments around safety reporting tasks and the setting up of client accounts. •Participating in audits where required and performing testing activities as needed. •Share ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives. Education and Experience: •Bachelor's degree or equivalent and relevant formal academic / vocational qualification •Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years’). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: •Strong knowledge of medical terminology •Good written and verbal communication skills •Good Microsoft Word and Excel skills and solid understanding of safety database functionality •Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines) •Ability to juggle multiple tasks while still delivering high quality results •Strong attention to detail and accuracy with orientation toward careful and meticulous work •Possess the maturity to handle sensitive information and data effectively •Ability to interact effectively with all levels of the organization •Strong critical...

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