Covance Drug Safety Officer Job Opening 2019- Application Details

t-align: center;">Covance Drug Safety Officer Job Opening 2019- Application Details

Drug Safety Officer Job Opportunity with the Biggest company Covance. Covance is one of the world’s largest and most comprehensive drug development services. Candidates looking for a good salary and a career in Drug management filed may apply for this job post. Check out all the details on the same below:

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Job Number 2019-28292

Work Location: Bangalore

Eligibility:

PhD / PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience) including 0-2 years of team leadership experience

For PharmD, a one-year residency of fellowship can be considered relevant experience.

Desirable:

  •  Pharmacy and Chemistry.
  • Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
  • Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.Team leadership experience includes experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives.
  • EudraVigilance Certification preferred

Experience

  • Strong relationship-building and interpersonal skills.
  • Good ability to assess staff performance and propose effective strategies to enhance existing strengths and fill any noted skill or knowledge gaps.
  • Good ability to propose solutions to effectively address any performance issues.
  • Ability to provide mentorship and guidance to project support staff.
  • Ability to grow and develop project support staff through multiple levels within the department career ladder.
  • Ability to coach project support staff in development of technical skills, efficiency and quality.
  • Ability to work independently in a staff management capacity, in regular consultation with management.
  • Ability to perform project review and process analysis, identify potential risks and process improvements – and propose appropriate action.
  • Functions as a positive, engaging and motivating team player.
  • Ability to direct, manage and coordinate the day-to-day efforts of multiple levels of staff.
  • Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.
  • Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources.
  • Good verbal, written and presentation skills.
  • Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
  • Work collaboratively with PV&DSS Management’s team
  • Leadership capabilities
  • Good Communication
  • High degree of accuracy with attention to detail.
  • Ensure client and global regulatory compliance.
  • Will present and share useful business information across departments and functions
  • Anticipate/identify problems and takes appropriate action to correct.
  • Knowledge of medical and drug terminology
  • Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
  • Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
  • Knowledge of Medical Device Reporting desirable
  • Knowledge of aggregate reporting desirable
  • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
  • Financially intuitive
  • Knowledge of ICH guidelines.
  • Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.

Job Overview

In your role as Associate Manager, Drug Safety you will

  • General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to, oversight of the following types of tasks:
    • Entry of safety data onto adverse event tracking systems
    • Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
    • Write patient narratives
    • Code adverse events accurately using MedDRA
    • Determine expectedness/listedness against appropriate label
    • Identifies clinically significant information missing from initial reports and ensures its collection
    • Ensure cases receive appropriate medical review
    • Prepare follow-up correspondence consulting with the medical staff accordingly
    • Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
    • Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
    • File maintenance

Apply Online

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