Chief Clinical Safety Specialist

Senior Medical Safety Advisor - Job Overview

The Senior Medical Safety Advisor plays a key role in the evaluation of safety data from various sources as part of the overall pharmacovigilance process. This position requires medical expertise to determine the medical and scientific relevance of serious adverse event reports within the context of a product's safety profile.

Main Responsibilities:

• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary.
• Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
• Provide coding review of AEs, SAEs, SADRs, past medical history, concomitant medications, or other medical data listings to verify and medically vet clinical data.
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
• Perform medical safety review of protocols, Investigative Brochures, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable.
• Provide aggregate reviews of safety information, including but not limited to clinical data, post-marketing, literature review, and observational studies to maintain oversight of a product's safety profile.
• Ensure service delivery from productivity, compliance, and quality perspectives within regulatory/contracted timelines. Lead and participate in initiatives taken for the same from team delivery perspectives.
• Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessments.
• Ensure update of watch lists, lists of expectedness, labeling lists/RSIs, etc. for assigned products and develop such additional capabilities within the team.
• Lead, drive, and participate in training activities, product transitions, audit preparation, and knowledge exchange initiatives.
• Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable.
• Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable.
• Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable.
• Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable.
• Maintain awareness of medical safety-regulatory industry developments.
• Provide support and participate in signal detection efforts, e.g., strategy meetings, etc. as applicable.

Required Skills and Qualifications:

• MBBS or MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.
• Three plus (3+) years of experience practicing clinical medicine after award of medical degree. Graduate and/or residency training is required.
• Two plus (2+) years of pharmacovigilance experience is required.
• Sound knowledge of Medicine.
• In-depth knowledge of applicable global, regional, and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of Pharmacovigilance- ICSR.
• In-depth knowledge of departmental standard operating procedures (SOPs).
• Skill in use of multiple safety databases.
• Adequate Computer skills, especially Microsoft Word, Excel & PowerPoint.
• Good communication skills - verbal and written.
• Ability to establish and maintain effective working relationships with managers, coworkers, investigative site staff, clients, and regulatory agency representatives.
• Valid medical license, or equivalent, from the country or region in which he/she resides and works preferred.