Associate Director -Drug safety Lead

16 Apr 2021
07 May 2021
Beata Klecz
Full Time
Contract Type
Experience Level

An existing opportunity has opened for MD (Physician) to take responsibility for leading safety projects for developmental and marketed products.
* Perform medical review of individual case safety reports (ICSRs) including the determination or confirmation of case reportability criteria, and the assessment of seriousness, expectedness and causality.
* Lead aggregate safety data reviews and contribute to the preparation of the medical content of periodic (including PSURs, DSURs) and ad-hoc reports. Review the safety sections of relevant labeling documents, identify and lead updates as required
* Lead regular and ad-hoc cross functional safety review teams. Represent pharmacovigilance on other multi-departmental projects
* Prepare and ensure the quality, consistency, and timely delivery of safety information for regulatory submission documents (including IND and NDA submissions). Author relevant sections of responses to safety related health authority requests
* Author and/or review relevant sections of various clinical documents e.g. Investigator's Brochures, clinical protocols, safety management plans, study reports, and integrated analyses
* Develop and maintain general safety signal management methodologies and product specific strategies
* Guide and train pharmacovigilance colleagues on medical assessment, signal detection and safety risk management practices
* Actively interact with external customers and service providers including business partners, CROs, system vendors and the call center
* Lead or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates
* Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented
* Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally


* M.D. degree required
* Strong experience in clinical practice or in academic medicine (preferred Experience in global drug development including epidemiology, clinical research, medical affairs or other relevant fields)
* Prior experience in pharmacovigilance including medical review, signaling and safety risk management
* Demonstrated ability to analyze and present complex pharmacovigilance data, experience with authoring medical evaluations and contributing to regulatory submissions
* Strong competency in understanding the scientific background of disease mechanisms and medical therapies
* Understanding of global pharmacovigilance regulatory requirements and guidance documents
* Ability to influence decision making around multifaceted issues involving medical safety
This opportunity offers interesting projects, further career development and flexibility for home/office work.

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.