HireDiversity

Leeds, GB

Medical Safety Officer EMEA-000009OE

Description

Job Title: Medical Safety Officer, EMEA

Division: DePuy Synthes Medical Affairs

Supervisor Title: Worldwide VP Medical Affairs/Reconstruction

Description

DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies is recruiting for a regional Medical Safety Officer (MSO) located in Europe, with responsibility across Europe, the Middle East and Africa (EMEA).

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The regional MSO role is to provide medical safety stewardship for DePuy Synthes products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. The regional MSO is an active member of a cross-functional team, and a close partner with the regional quality leader and statistical colleagues, in assessing any potential safety signal for a DePuy Synthes product. The regional MSO plays a pivotal role in evaluating customer/user risk and in assessing the real or potential impact of product performance issues on patient safety. The reactive elements of the role (addressing Quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities which should be taken to minimize potential risk to patients. Further, the regional MSO must be a credible partner in the innovation process, engaging with R&D and quality engineering to drive Medical Devices & Diagnostics' patient-centered innovation process.

The regional MSO will assess product risk-benefit, and provide medical input/review to regional response to AEs, complaints and mass communications, review internal and customer safety training materials, input into design and interpretation of regional safety related studies, and results of any Safety Surveillance Plan activities, evaluation of medical impact of manufacturing issues and clinical interpretation of: Pre- and post-marketing safety data, aggregate complaint data, individual case safety reports and literature reports with possible safety data. The regional MSO will also take responsibility for the Medical Monitoring of clinical studies as assigned.

The regional MSO will provide medical safety expertise, oversight and guidance as it relates to the performance and impact of products. Contribute to and continually review the definition of a product's harms and hazards list and derivations of criteria for reportability. Review and approve (from a medical safety perspective) appropriate regional reports and filings. Advise on regional failure investigations and provide medical opinion when deciding on reportability. Act as subject matter expert in audit and other regional regulatory body interactions. Interface with customers/users to gather additional medical information/data when required to support investigations. Provide customized responses to, for example, regulatory bodies, clinicians and patients. When required, provide additional safety related information to customers to prevent repeat adverse events and complaints. Monitor external regional sources/trends (including national and institutional registries) and identify and escalate emerging issues. These include (but are not limited to): regional complaint & Medical Device Reporting trends and regional regulatory & market trends/intelligence. Be the regional medical representative within the escalation process when making decisions on field actions; and to evaluate the effectiveness of regional field safety corrective actions. Ensure consistency in medical evaluations, Quality Review Board escalation, and overall Safety evaluations of products. Ensure appropriate metrics are used to assess adequacy of patient safety related processes.

In addition to safety responsibilities, the Regional MSO will oversee and provide expert medical & scientific support to Regional Regulatory Affairs, Communications, Legal, and QA/Risk Management / Product Safety teams. The Regional MSO will consult and liaise with Regional Clinical Research, Regulatory, R&D and Commercial teams by providing medical and scientific expertise to drive optimal business strategic direction and tactical business activities, including: product launches; key scientific meetings; relationship management with leading research physicians and professional bodies, medical delivery system or government decision makers; collaborative and development activities with registry and evaluation bodies; critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.

The regional MSO will oversee scientific and medical accountability for requests for scientific information and provide scientific and medical expertise in the assessment of requests for Investigator Initiated Research Grants from the region. In collaboration with Operating Companies, oversee regional investigator initiated studies to ensure optimal strategic and scientific synergy between Medical Affairs and Commercial organizations across the region.

Qualifications

- A Medical Degree, such as MB BS or equivalent designation is required for this position. Clinical experience in a relevant specialty is preferred. Additional PhD, MBA, MHA, or MPH is an asset.
- A minimum of two years hands-on patient management experience (clinical practice) is preferred.
- A strong background and experience in the medical device or pharmaceutical industry (medical device, biologics, and/or drugs, or combination products) is required. This experience must be in medical affairs, safety, or clinical research. A minimum of 3 years previous industry experience in EMEA region is required.
- A sound understanding of identifying safety signals & safety reporting processes is required.
- Demonstrated business acumen, leadership skills, mentoring skills and the ability to make quick decisions.
- Excellent communication skills, including written communication (e.g., peer review publication) and oral presentation of scientific materials and research results. Ability to write original scientific documents such as clinical summaries, regulatory filings, investigator brochures, and internal reports and scientific publications.
- Ability to communicate effectively, orally and in writing, with many levels of employees of various disciplines within various departments.
- Ability to build successful relationships with key stakeholders in the region
- Excellent public speaking, communication, leadership, organizational, interpersonal, and reasoning skills
- Teaching skills, including both oral and hands-on education of health care professionals and company employees on scientific and medical issues surrounding company products and on optimal safe and effective use of products.
- Knowledge of Quality Management System requirements is preferred. Knowledge of regional medical device safety regulations is preferred. Travel of 20 to 30% is required.

Closing Date: 8th February 2013

We respectively request Government Officials to identify themselves as such on application for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson and Johnson Medical, a Johnson and Johnson Company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.

Primary Location:Europe/Middle East/Africa-United Kingdom-England-Leeds
Organization: Depuy Int'l Ltd. (8722)
Travel:Yes, 25% of the time
Job Function: Medical Affairs