Drug Safety Specialist Job at CEDENT, New York, NY

VWZZbVpjcnVOazZnVzFxWjllQ2NHdm9Ma2c9PQ==
  • CEDENT
  • New York, NY

Job Description

Job Overview:
We are seeking a detail-oriented and dedicated Drug Safety Specialist to join our team. In this role, you will play a key part in monitoring and assessing the safety of our products, ensuring compliance with global pharmacovigilance regulations and contributing to the safety and well-being of patients worldwide. You will work closely with cross-functional teams to ensure that all safety information is accurately reported and managed, helping to uphold the highest standards of drug safety.

Key Responsibilities:

  • Monitor and evaluate the safety profiles of our products, ensuring compliance with global pharmacovigilance regulations and internal policies.
  • Conduct thorough review and analysis of adverse event reports, medical literature, and safety data to identify any potential safety concerns.
  • Collaborate with cross-functional teams to facilitate timely and accurate reporting of adverse events to regulatory authorities.
  • Develop, implement, and maintain processes and standard operating procedures to ensure adherence to pharmacovigilance guidelines and regulations.
  • Provide guidance and support to internal teams on safety requirements, pharmacovigilance processes, and best practices.
  • Serve as a point of contact for external partners, including CROs and regulatory agencies, regarding drug safety issues and concerns.
  • Participate in the development and maintenance of risk management plans and safety-related documents for our products.
  • Conduct safety assessments, signal detection, and risk-benefit analysis to identify potential safety signals and ensure effective risk management.
  • Communicate relevant safety information to healthcare professionals, patients, and regulatory authorities as necessary.
  • Stay up-to-date with changes in pharmacovigilance regulations, guidelines, and industry trends, and implement any necessary updates to processes.
  • Participate in audits and inspections related to drug safety activities, ensuring compliance with all applicable standards.
  • Train and mentor new members of the drug safety team, providing support and sharing expertise as needed.
  • Engage in cross-functional projects and initiatives aimed at improving and optimizing drug safety processes.
  • Maintain accurate and complete documentation of all drug safety activities in compliance with regulatory and company standards.

Qualifications:

  • Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
  • 2+ years of experience in drug safety, pharmacovigilance, or a related area within the pharmaceutical or biotech industry.
  • Strong understanding of global pharmacovigilance regulations and guidelines.
  • Experience in safety data review, adverse event analysis, and signal detection.
  • Excellent communication and interpersonal skills, with the ability to work effectively across teams and with external partners.
  • Strong analytical skills, attention to detail, and the ability to interpret and communicate complex safety data.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with safety databases or pharmacovigilance systems.

 

Job Tags

Contract work, Worldwide,

Similar Jobs

Applewood Centers

Group Therapeutic Services Program Intern Job at Applewood Centers

 ...lives. Position Summary : As the Group Therapeutic Services Intern, you will work under the supervision of the After School Group Therapeutic...  ...in a related Masters program is required. An SWT, CT, LPC, MFT or LSW is required. #LI-Hybrid Applewood Centers,... 

Moffitt Cancer Center

Oncology Medical Spanish Interpreter Job at Moffitt Cancer Center

 ...Req # 81169 JOB SUMMARY: The Oncology Medical Interpreter I provide interpreting services to Limited English Proficiency patients and Moffitt Cancer Center providers during clinical and non-clinical encounters selecting the appropriate interpreting mode for the encounter... 

Mystique Transport

CDL A Truck Driver| Regional| Dedicated Job at Mystique Transport

 ...No touch freight All Drop and hooks 2000-2500 miles a week Dedicated customer Driver bonuses Accessory pays Steady Freight Minimum Pay guarantee Must haves: Must have a valid CDL A license Must have 1 year of recent experience Must be able... 

Job Site Resources

Superintendent Water/Wastewater Job at Job Site Resources

Construction Superintendent Water/Wastewater Skills/Qualifications: - prior experience as a Superintendent- 5 years (preferred) water/wastewater treatment plant exposure- ideal candidate will be comfortable overseeing the entire field operation of a water/wastewater... 

Mondo

Senior Content Designer Job at Mondo

Apply now: Senior Content Designer, this is a 100% remote opportunity. The start date is ASAP for this long-term contract positio n Job Title: Senior Content Designer Location-Type: 100% Remote Start Date Is: ASAP Duration: Contract...