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Drug Safety Specialist

2+ years
Preffered by Company
10 Aug. 26, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Safety Coordinator

Location: India

Company Overview:

Medpace is a global leader in clinical contract research services, providing comprehensive Phase I-IV development solutions to the biotechnology, pharmaceutical, and medical device industries. Our mission is to advance the development of safe and effective medical therapeutics through a disciplined and scientific approach. Headquartered in Cincinnati, Ohio, with operations in over 40 countries, Medpace brings local regulatory and therapeutic expertise to a wide range of therapeutic areas, including oncology, cardiology, metabolic diseases, endocrinology, central nervous system disorders, and anti-viral and anti-infective treatments.

Role Summary:

We are looking for a full-time Clinical Safety Coordinator to join our Clinical Safety department in India. This role focuses on the handling and processing of adverse events from clinical trials and post-marketing surveillance. If you are looking to advance your career in a dynamic environment while leveraging your expertise, this is an exciting opportunity for you.

Responsibilities:

  • Action Planning: Determine appropriate actions for incoming calls related to adverse events.
  • Adverse Event Processing: Collect, process, and track adverse and serious adverse events from all sources.
  • Safety Narratives: Write detailed safety narratives for reported events.
  • Reporting: Prepare and report on various safety data.
  • Collaboration: Work with internal departments and clinical research sites to ensure compliance with safety processes and protocols.

Qualifications:

  • Education: Bachelor’s degree in a healthcare-related field (e.g., Nursing, Pharmacy, Pharmacology).
  • Experience: Clinical experience or background in Clinical Research, case processing, and post-marketing pharmacovigilance preferred.
  • Skills: Proficient in English with strong organizational and communication skills.
  • Technical Proficiency: Knowledge of Microsoft® Office and a broad understanding of medical terminology.

Why Medpace?

At Medpace, we are driven by our commitment to People, Purpose, and Passion. Join us to make a meaningful impact on patient lives and advance your career in a supportive and innovative environment.

Medpace Perks:

  • Work Flexibility: Hybrid work-from-home options based on position and level.
  • Generous PTO: Competitive paid time off packages.
  • Employee Engagement: Company-sponsored employee appreciation events and health and wellness initiatives.
  • Work-Life Balance: Flexible work schedules and a competitive compensation and benefits package.
  • Career Development: Structured career paths with opportunities for professional growth.

Awards:

  • Top Workplace Recognition: Named a Top Workplace in 2024 by The Cincinnati Enquirer.
  • Forbes Recognition: Recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
  • Industry Excellence: Continually honored with CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

Join Us Today:

If you are a dedicated clinical safety professional with a passion for making a difference, apply now to become a key part of our team at Medpace.