Safety Specialist
Novella Clinical - Durham, NC

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We are proud to be an EEOBASIC FUNCTIONS:
Delivering drug safety services and ensuring that safety reports are processed and reported according to ICH-GCP guidelines, regulatory requirements and PharmaLinkFHI SOPs or procedures agreed with the Sponsor.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Execution of work strategy of the Pharmacovigilance Department including the receipt, monitoring, processing, entry and reporting of safety reports. Ensures the accuracy and completeness of safety information entered in the SAE tracking system, safety database and compilation of individual and aggregate safety reports for submission to regulatory authorities. Execution of all safety services as outlined in SOP, Safety Management Plans and relevant Contracts.
• Ensures compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to PVG
• Prioritizes time effectively based on project needs. Consistently meet deadlines. Able to track compliance with study timelines. Seeks management input with any difficulties in establishing priorities.
• Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
• Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
• Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
• Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
• Establishes and maintains effective relationships with customers (clients and site personnel) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
• Perform other related duties as assigned or requested by the Manager, Pharmacovigilance.

KNOWLEDGE, SKILLS AND ABILITIES:
• Demonstrates expertise in safety and pharmacovigilance.
• Knowledge of clinical research process and medical terminology.
• Strong written and verbal communication skills to express complex ideas.
• Able to develop knowledge of the disease under study. Able to discuss simpler aspects of the disease process with site personnel and colleagues.
• Ability to organize, plan and execute projects, including the ability to delegate and guide the work of others to achieve project completion timelines and quality standards.
• Able to develop knowledge of protocol, regulatory requirements and company SOPs. Familiar with matrix team structure and phases of research. Able to identify and document protocol violations, regulatory non-compliance, and any issues involving subject safety.
• Good organizational and interpersonal skills.
• Ability to reason independently to assess and recommend specific solutions in a clinical setting.
• Attention to detail. Able to identify and resolve discrepancies on SAE reports and case report forms.
• Understand electronic data capture including basic data processing functions.
• Understand current ICH/ GCP guidelines applicable to the conduct of clinical research.
• Demonstrates professionalism and presents a positive image of the company.
• Demonstrates excellence in customer service.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
• Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:
• Bachelor's level degree in life sciences, pharmacy, nursing or RN, or equivalent clinical research experience.
• Minimum of 4 years of experience in Pharmacovigilance
• Computer literacy required; Knowledge of electronic data capture preferred.
• Must possess good written and verbal communication, interpersonal, and organizational skills. /AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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