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Leeds, GB

Medical Safety Specialist EMEA-000009OG

Description

Job Title: Medical Safety Specialist, EMEA

Division: DePuy Synthes Strategic Medical Affairs

Supervisor Title: Medical Safety Officer, EMEA

Description

DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Medical Safety Specialist. This position is located in Leeds, UK.

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.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The regional Medical Safety Specialist, EMEA ensures that reports of safety information are documented, processed and reported following Company guidelines, internal business practices, and regulatory guidance to ensure compliance with worldwide/EMEA safety regulations and corporate policies. This position will provide timely and careful documentation and investigation into reported incidents and provide the company with up-to-date safety information on products.

The Regional Medical Safety Specialist - EMEA will work collaboratively with a global Medical Safety team, based in the USA, and will report to the Regional Medical Safety Officer - EMEA. He/She will have responsibility for the following areas:
- Medical Safety Issues Management Support: manage medical safety issues and medical complaint/adverse event investigation and follow-up.
- Medical Input to Health Risk Assessment - e.g., FMEA, risk analyses, product inserts, literature reviews, historical/product inquiry data, and clinical readiness review, etc.
- Post-Market Surveillance Support - product safety performance report preparation and communicating business related issues or opportunities to next management level.

The regional Medical Safety Specialist will also support the regional Medical Safety Officer EMEA by:
- Providing initial medical safety information to support Medical Affairs' position on the performance and impact of products;
- Contributing to the definition of a product's harms and hazards list; Contributing (from a medical safety perspective) to appropriate regional reports and filings;
- Engaging in regional failure investigations and provide opinion when deciding on reportability;
- Providing data to support audit and other regional regulatory body interactions;
- Interfacing with customers/users to gather additional medical information/data when required to support investigations;
- Providing input to responses to, for example, regulatory bodies, clinicians and patients;
- Assisting in the monitoring of 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;
- Ensuring consistency in medical evaluations, Quality Review Board escalation, and overall Safety evaluations of products;
- Applying appropriate metrics to assess adequacy of patient safety related processes.

Qualifications


Qualifications


The successful applicant must be a qualified Nurse, or hold MPharm or MBBS (or equivalent degrees) with a minimum of 2 years of experience in related therapeutic area(s) (i.e. joints/neurology/sports/spine/trauma) for this position. A minimum of 2 years of experience in the Pharmaceutical or Medical Device Industry is preferred.

Candidates for this position must possess medical knowledge of adverse events associated with medical procedures. Knowledge of regulatory requirements for the handling of adverse events/complaints is preferred.

Knowledge of medical device risk management processes is preferred as is knowledge and experience of common biostatistical methods. Broad knowledge of orthopaedic or neurological products and clinical applications of such products is also preferred.

Strong verbal and written communication skills, the ability to multi-task, effective time management skills and strong organizational skills are required, as is proficiency with the Microsoft Office suite of products. Medical writing and presentation skills are preferred.

Closing Date: 8th February 2013

We respectively request Government Officials to identify themselves as such on application for the purpose of the Foreign Corrupt Practice Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & 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)
Job Function: Medical Affairs