Associate Medical Safety Director - Home Based in Europe
Syneos Health
Based, Home, BEL, Belgium
1 dag geleden

JOB SUMMARY

Interacts with customers, and project teams providing medical expertise related to Safety and

Pharmacovigilance (SPVG) activities for investigational products in clinical trials and post-approval

marketed products. The position is responsible for providing medical guidance and performing medical

review of Individual Case Safety Report (ICSR) and Safety Aggregate Reports. The position conducts

medical assessment of all safety related data and ensures medical accuracy of case narrative, coding

and appropriate medical interpretation of all cases. The position is responsible for providing safety

management, medical oversight and assessment of pharmacovigilance activities as assigned. Actively

supports signal detection, monitoring, and analysis activities, and the generation and review of risk

management guidelines.

JOB RESPONSIBILITIES

Performs and oversees medical review of adverse events reported for both investigational and

marketed products

Maintains familiarity with MedDRA, WHO-DRL and safety databases such as ARGUS.

Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.) and provides

an analysis of similar event (AOSE), as appropriate

Identifies, communicates and effectively manages potential safety issues

Works closely with SPVG colleagues to ensure appropriate medical interpretation and consistency

are applied to adverse event case assessment

Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of

clinical safety information

Stays abreast of clinical and drug development information relevant to contracted programs

Provides investigator support regarding safety concerns, medical emergencies, etc.

Participates in medical safety surveillance / signal detection benefit / risk assessment, and development

of trend analyses

Participates in development of REMS and RMP as required

Discusses and resolves medical issues with clinical sites, clients, and SPVG staff

Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports,

PSURs, PADERs)

Participates in meetings specific to medical safety assessment, such as Drug Safety Committee

DSC) meetings

Consults with internal and external customers in the area of Safety and Pharmacovigilance

Supports business development through participation in core proposal team activities, feasibility

assessments and review of proposals / contracts for medical services

Maintains medical and pharmacovigilance expertise through appropriate continued medical education

CME)

Responsible for performing activities that are in compliance with applicable Corporate and

Departmental Policies, Standard Operating Procedures, Work Instructions and project specific

Operating Guidelines

Supports business development activities as required

Serves as a mentor and trainer for internal SPVG staff including Safety Physicians

Provides medical safety expertise for clients and the company

Provides medical leadership for assigned projects

Participates in investigators’ meetings to provide training on regulatory requirements for adverse

events reporting as required.

Performs other duties as assigned by management

Qualifications

The incumbent should possess M.D., B.M.B.S., D.O. or equivalent combination of education andexperience Completed an accredited residency Knowledge of global pharmacovigilance regulations and processes Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook),TeamShare (or other management / shared content / workspace), safety databases, and internet Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability toinform and influence Ability to multitask under tight deadlines while providing attention to detail and high quality work in adynamic environment Ability to be flexible, adapt to change, work independently, as well as experience working in a matrixenvironment Ability to be customer-focused and have a disciplined approach to work Ability to travel as necessary (up to 10%)

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