We are currently seeking a Senior Clinical Research Associate to join our growing team. The role will include the following:

• Responsible for Medical Review activities
• Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous, and solicited reports
• Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
• Perform triage of cases and determine seriousness and relatedness across products as assigned
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
• Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
• Conduct assessment of litigation cases across products as assigned
• Identify and resolve case issues, co-ordinate with client therapeutic teams/site for specific products or functional groups
• Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
• Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
• Perform literature review activities and provide medical judgements for ICSRs, aggregate safety reports, Signal reports and RMP
• Prepare and medical review of periodic aggregate safety reports, Signal reports and RMP
• Support the preparation and maintenance of safety sections of the Company Core Data Sheet
• Resolution of site level issues and where necessary escalation of issues to PM
• Lead/support PDS post-marketing safety study activities
• Carry out signal detection activities and evaluation
• High level of proficiency of all workflow tasks.
• To work independently but guided by documented procedures, with appropriate support.
• Following up with sites regarding outstanding queries.
• Follow up on reconciliation of discrepancies.
• Mentor and guide the activities of Junior Medical Reviewers.
• To work as subject matter expert

• Good understanding of medical matters
• Good knowledge of GCP and pharmacovigilance principles and related guidelines and regulations
• Basic competence with medical and therapeutic terminology
• Understanding of patient safety regulatory obligations
• Should be familiar with regulatory and pharmacovigilance guidelines
• Good command of written and spoken English; additional languages favourable
• Good knowledge of usual office software (MS Office: Word, Excel, PowerPoint)
• Experience in database handling, data entry (e.g. ARGUS, ArisG)
• Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability, commitment and capacity for team-work)