Drug Safety Specialist (Temp)

The Drug Safety Specialist for the purpose of safety reporting in clinical trial and post-marketing as required by the study awards, need to ensure understanding, implementation and compliance with the relevant regulations and Standard Operating Procedures (SOPs). The role will focus on safety reporting : expedited & periodic reporting (not SAEs case processing) e.g. SUSAR/DSUR to Regulatory Authorities / Ethics Committees / Sites for trials conducted wordlwide.

This is a temporary (contractor) role for 6 month with a view of extension.

Key Responsibilities: Maintaining a good working knowledge of the international regulations SOPs, and client’s guidelines, as applicable Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting Assist in development of project specific safety procedures, workflows and templates. Preparation for, participation in, and follow up on audits and inspections Determining reportability of the safety reports to RA/EC/Sites Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy) Submission of safety reports to investigators via SIS (Safety Information System) Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client (as contracted) Configure project specific safety database, and customize data entry guidelines, if applicable Create and maintain project specific working files Participate in client and investigator meetings as required Register with relevant authorities for electronic reporting (eg EudraVigilance, portals etc) on behalf of sponsor Prepare the regulatory reporting requirements table to regulatory authorities, CECs, local ECs, and investigators involved in the study Unblind SUSARs, as locally required prior to submitting to regulatory authorities / CECs (investigators receiving blind safety reports) Perform QC Tracking and filing of submitted safety reports (expedited and periodics) in study-specific tracker and eTMF Maintain compliance metrics (KPIs) Support the safety intelligence department "Global Pharmacovigilance Information Office (GPIO)" with the collection of global regulatory requirements QualificationsSkills and Experience required for the role: Degree in life Sciences, Health or Biomedical Sciences (a degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage) 2-3 years of related experience in drug safety/ pharmacovigilance Knowledge of and ability to interpret and apply global safety regulations Sound knowledge of drug safety and the drug development process Clear understanding of the regulatory submission process Proficient in database Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to evaluate data and draw conclusions independently