Pharmacovigilance & Risk Management Physician

ProClinical Ltd
13 Nov 2017
15 Nov 2017
Contract Type
Full Time
The Benefit-Risk Management Physician (also generally to as safety physician) is responsible for the medical expertise on all aspects of safety throughout the entire lifecycle of the assigned company product(s). The BRMP will apply sound medical judgment for the analysis and interpretation of complex data for signal detection, substantiation and initiation of safety risk management activities including and not limited to risk minimization activities (studies, registries, real world databases) and evaluation of the effectiveness of risk mitigation measures. The role integrates these safety risk management activities of a given product, into the regulatory and business context.

The BRMP must have expert scientific and medical knowledge of the company therapeutic area and international standards and expectations, including and not limited to Good Vigilance Practice as defined by the EMA.

The BRMP will apply sound medical judgement for analysis and interpretation of complex safety data for signal detection/substantiation and initiation of safety risk management activities including safety specification, PV planning, risk minimization/mitigation and evaluation of effectiveness of risk mitigation measures. The role ensures the integration of benefit risk management tools/expertise into a medical, business or regulatory context of the products. The BRMP brings her/his expertise and represents Pharmacovigilance in the cross-functional clinical development meetings.

Job Responsibilities:

* Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life cycle of a defined portfolio of medicinal products.
* Lead the cross-functional Safety Management Teams regarding safety relevant topics and escalate all safety relevant matters to the appropriate decision-making level with proposals for solutions based on analysis of the available information.
* Is accountable for the appropriateness of the content of safety documents such as RMPs, PSURs, DSURs, and safety sections of CSRs, labelling documents. As well as safety sections and/or manuscripts/publications related to safe use of an assigned product.
* Support clinical development programs including post-approval commitments regarding all aspects of clinical safety.
* Provides strategic safety input to key stake holders in relation to product safety, understanding the business strategy for the product and be knowledgeable about the (medical) context of the respective product class. Interface with other departments (e.g. clinical development, regulatory, epidemiology, medical affairs) with regard to safety aspects.
* Ensure regulatory agency inspection findings and internal audit findings relating to signal detection, evaluation and risk mitigation are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively as required. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous quality improvement of pharmacovigilance procedures and processes.

Skills and Requirements:

* 5 to 7 years of experience in Benefit-Risk Management and Clinical Trial Safety is required, in all aspects of Benefit-Risk Management (risk identification; risk assessment; risk communication; risk mitigation; evaluation of risk mitigation).
* Exposure to Clinical Development and/or clinical safety of at least 1 product submitted to Regulatory Authorities for marketing authorization.
* Expert in the Safety Regulations with comprehensive knowledge of global drug/vaccines safety regulations, guidance (including European GVP) and best practices.
* Understanding of current approaches to balancing the benefits and risks of company products, in particular, experience developing and implementing a risk management plan acceptable to FDA and EMEA.
* Familiarity with cross functional principles of drug development, pharmacology, biostatistics, clinical trial methodology, pharmacoepidemiology, medical safety and pharmacovigilance. Sound clinical acumen and in depth therapeutic area/product knowledge and able to assess, manage and communicate appropriately with respect to the safety profile of medicinal products
* Strong communicator with excellent English language skills, both written and spoken, ideally with demonstrable experience in medical and scientific writing
* Good networking and team skills for successful cooperation with internal and external customers
* Self-confident, proactive and decisive
* Excellent communication skills, including formal presentation skills.
* Ability to thrive in a global, matrix environment as a team player.
* Ability to successfully manage and prioritize multiple critical issues simultaneously.
* Minimum educational level necessary to perform the job (High School diploma, Assoc Degree, Bachelor's D