IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Post : Senior Manager, Safety Management
Job description
• Assists Safety Leadership (Assoc Director level & above) with designing and planning the work strategy of the Safety Management Department.
• Implements Safety Management Department work strategy through delegation, mentorship and supervision of Safety Management Department staff and studies.
• Oversees the start-up and ongoing conduct of Safety Management services for new studies, providing guidance and mentorship to Safety Management Lead and staff as needed. Communicates regular updates and promptly escalates any issues or concerns related to study conduct or staff performance to applicable Safety Leadership.
• Writes and/or provides input to department specific SOPs and Working Practices.
• Monitors and manages the daily activities of members of the Safety Management Department including authorizing leave and conducting performance appraisals.
• Provides ongoing coaching and development for staff assigned to project teams, if applicable.
• Organizes and gives training sessions for project teams and Safety Management Department to ensure quality of all safety data.
• Assists Business Development in all safety related issues required for the preparation of proposals/ contracts for potential sponsors. This involves participation in teleconferences and bid defense presentations as needed.
• Performs other related duties as assigned or requested by the Safety Leadership.
KNOWLEDGE, SKILLS AND ABILITIES:
• In depth knowledge of clinical research process and medical terminology.
• Broad based expertise in clinical trial safety.
• Excellent written and verbal communication skills. Able to effectively express complex ideas.
• Positive attitude and ability to interact effectively with all levels of staff to successfully coordinate, execute and oversee Safety department activities and staff.
• In depth knowledge of issues/considerations involved with collecting safety data in an electronic data capture environment.
• In depth knowledge of current ICH/GCP guidelines applicable to the conduct of clinical research.
• Excellent organizational and interpersonal skills.
• Ability to reason independently and effectively problem solve complex issues.
• Excellent attention to detail.
• Demonstrates excellence in customer service and professionalism.
• 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.
• Independently prioritizes time effectively based on department needs. Consistently meets deadlines.
Candidate Profile
• Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
• Minimum of 7 years of relevant experience in clinical trial safety.
• History of strong leadership skills including supervisory experience desirable, but not required.
• Equivalent combination of relevant education and experience.
• Advanced computer literacy and skills in working with Microsoft Office (Word, Excel, PowerPoint) required
• Knowledge of electronic data capture systems and safety database systems required.
• Excellent verbal and written communication skills required.
• Excellent interpersonal and organizational skills required.
• Ability to work independently, prioritize effectively and work in a matrix team environment required.
• Ability and willingness to travel domestically and internationally as required; ability to rent automobile.
Additional Information
Experience : 7 years years
Qualification : Bachelor's Degree
Location : Bangalore, India
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R1181973
End Date : 30th April, 2021
Send your resume to niffi.abdulrahiman@iqvia.com or muhammed.nazeemkk@iqvia.com
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