Work Site/Location: Remote
Work Schedule: 8 hours a day M-F flexible on hours.
Must Have Skill : 1. .Medical Degree (does not have to be licensed within the US but needs to be Medical Degree.
2. .Patient care experience
3. experience within the Neurosurgical side
Description: The Medical Safety Specialist (Client) applies medical/clinical experience and product knowledge to multifunctional teams (i.e., Clinical, Quality, Risk Management, Complaint Management and Medical Affairs) to deliver product safety guidance to NPI and sustaining teams throughout the entire product lifecycle.
The Client participates in all activities related to the safety and performance of any post-market product or investigational product in development.
Candidates utilize their knowledge of evolving global regulations and provide safety input to all internal and external customers and stakeholders inclusive of leading or contributing to the review and composition of clinical/regulatory reports and correspondences with global regulatory authorities.
Risk documentation development and utilization for safety signal detection and reporting. Safety management responsibilities required for clinical study program oversight inclusive of adverse event adjudication, MedDRA coding, and management of escalation of events to Complaints and reporting to ethics boards per their requirements.
Additional responsibilities include Medical Device Technical File support for EUMDR remediation activities as needed.
Development of departmental policies and procedures.
Candidates must have in-depth knowledge of all assigned products, along with their surgical technique, and follow-up care treatments, or therapies.
Create, edit, review, and/or approve all labeling i.e., understand the device and device use, patient population/intended user, indications for use, alternative therapies and treatments, contraindications, clinical benefits, and the potential complications and required warnings and precautions required to be included in the labeling.
Adjudicate adverse events related to all products to ensure accuracy, integrity and completeness of safety information.
Consistency code adverse events via MedDRA requirements.
Participate in safety signal detection activities to allow signal identification, evaluation, validation, and management for marketed products including individual and aggregate data analyses, interpretation of safety signals and trends, documentation and communication of safety risks in collaboration with key internal and external stakeholders.
Assist internal and external stakeholders, including Regulatory, and Quality Assurance customers and regulatory bodies in evidenced-based and historical data regarding medical safety.
Assist in post-market review of potential safety concerns identified through multiple departments, including Quality, Clinical, Regulatory and Product Quality.
Provide Medical Assessments for new or unusual safety matters that involve critical, death or legal issues. Investigates the relationship to the device; and determines potential escalation.
Participate in Product Safety Review Board; biweekly review of potential safety issues identified through post market monitoring. Discuss particulars of the Medical Assessments
Collaborate with appropriate investigational personnel, clinical, and/or Complaint or Quality assurance personnel regarding returned product analysis.
Participate in clinical protocol development for inclusion of safety requirements.
Draft Safety Management Plans for clinical studies.
Quality partner, providing medical input in the development and update of risk documentation (BRA, FMEAs), field actions, and draft Health Impact Assessments for inclusion into risk documentation and or Health Hazard Evaluations for field safety actions and communications.
Investigates specific events by contacting internal resources, field employees, HCP customers and international staff as appropriate.
Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.
Collaborate with other team members and work under the direction of Medical Safety Director.
Maintain knowledge of relevant regulations for classifying and reporting medical device and drug adverse events.
Ability to review and summarize medical literature.
Maintain team relationship within the organization (domestic and international) through effective and timely communication.
Participate in team meetings to provide updates to all assigned activities and address safety- related concerns.
Develop Pharmacovigilance training materials, and conduct training presentations.
Ability to identify and respond to critical issues and problems for immediate corrective action resolution.
Support the following activities not limited to:
Pharmacovigilance of all products
Adjudication of adverse events
EUMDR Remediation activities
Health Hazard Evaluations
FDA Responses
Clinical study support
Investigational Device Exemption activities
Creation of summaries from reviewed medical narratives
Collaborate with all divisions and teams.
Provide input for clinical/regulatory reporting.
Minimum Requirements: Medical degree with minimum of 5 years relevant experience in a clinical setting involving patient care to fully understand disease states and diverse treatment options, expected outcomes and complications of treatments.
5+ years preferable experience in the medical device industry.
Medical Affairs/Safety or Clinical Management experience with the ability to perform patient assessments.
Ability to follow national and international regulations and reporting requirement for adverse events, medical device complaints.
Experience analyzing medical/scientific data and demonstrate knowledge of principles of device development, pharmacology, clinical trial methodology and design, assessment of drug/device risks and benefits, and safety assessments for both marketed devices and those in development.
Necessary Skills and Abilities Include: Proficient in Microsoft Office Suite (Outlook, Word, Excel) and TrackWise adverse events reporting software.
Working knowledge of FDA guidance for clinical safety surveillance
Excellent internal and external customer communication skills demonstrating strong verbal, written and interpersonal skillset.
Strong organization and prioritization skills.
Strong attention to detail.
Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge.
Able to work independently and collaboratively in a multidisciplinary team. •
Last updated on Oct 12, 2023