Job Description
Position Summary:
Located within CSL’s Global Regulatory And Safety department, the Medical Evaluator oversees a team of
medical evaluators at the vendor side to achieve high quality, consistent, and timely evaluation of case reports entered in the global GSPV database as specified by regulatory guidelines and CSL SOPs.
Interaction and cooperation with other functions is crucial to assure high quality assessments, aggregate reports, and continuous improvement in an environment of rapidly changing regulations and
expectations of regulatory authorities.
Assure that new regulatory requirements are followed without undue delay and that appropriate training efforts are undertaken. Liaison and close cooperation with interfacing departments, including but not limited to Clinical teams are key for high quality early and late-stage product development and maintenance.
Primary Accountabilities:
- Support the Director, Medical Evaluation and Case Processing Oversight, to manage individual Medical Evaluation.
- Quality Management: Ensures timely and quality assessment of medical report cases, and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs.
- Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to medical evaluation of cases.
- Inspections: Ensures regulatory agency inspection findings and internal audit findings relating to the medical assessment processes are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function.
- Trains and acts as mentor of vendor medical evaluators: Contribute to the onboarding and mentoring of other member of the global team around a clear set of standards and strategic objectives
- Provide vendor oversight and guidance to ensure high quality and timely processing of individual case safety reports
Qualification and Experience Requirements:
Advance Medical degree (e.g. MD) or international equivalent.
5 (five) years pharmaceutical Min./ CRO industry experience, of which at least five (2) should be in a medical evaluation role, with broad overview of all aspects of a PV system and specific experience in regulatory requirements.
Competencies:
PV Acumen: Deep knowledge of:
· Structure, key stakeholders, and interdependence of the PV system
· Business environment of a pharmaceutical company and how safety decisions can impact other functions and patients.
· PV concepts (e.g., CIOMS, listedness/expectedness, causality assessment, common AE grading and coding conventions, ICSR mgmt.)
· PV documents and safety sections of documents (e.g. PBRER, RMP)
· Safety sections/required safety contributions to regulatory submission documents (e.g., as part of MAA, renewals, CTD, IB, etc.).
· Labelling principles and key regional differences in displaying safety info.
· Relevant regulations and key regulatory milestones including timing of key opportunities to have an open dialogue with Health Authorities
Communication
· Conveying complex concepts through clear and concise messages
· Demonstrating two-way communication, by seeking and incorporating feedback to improve outputs and alignment
· Preparing and delivering professional presentations to colleagues, tailoring messages, and communication methods to the needs of the audience
Leadership
· Demonstrating independent thinking and techniques to support position
· Engaging and influencing cross-functional stakeholders to ensure that safety is included in relevant discussions
· Providing appropriate direction, gaining commitment, developing, and empowering others. Where required, managing conflict appropriately. Adapt leadership style to different situations, individuals, and cultural differences.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.