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Drug Safety Specialist/ Clinical Safety Coordinator

0-2 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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: Drug Safety Specialist / Clinical Safety Coordinator

Location: Navi Mumbai, India
Job Type: Full-time, Office-based


ABOUT MEDPACE

Medpace is a leading full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. With over 5,000 employees across 40+ countries, Medpace is dedicated to accelerating the global development of safe and effective therapeutics through a scientific and disciplined approach. We leverage local expertise across therapeutic areas such as oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective.


JOB SUMMARY

Medpace is currently seeking a full-time Clinical Safety Coordinator to join the Clinical Safety department in Navi Mumbai, India. This role involves the handling and processing of adverse events from clinical trials and post-marketing surveillance. The ideal candidate will have clinical or pharmacovigilance experience, along with the ability to grow and develop within the role.


KEY RESPONSIBILITIES

Adverse Event Handling & Safety Reporting

  • Determine and establish the plan of action for incoming calls related to safety concerns.
  • Collect, process, and track adverse events, including serious adverse events (SAEs) from clinical trials and post-marketing surveillance.
  • Write safety narratives to describe the nature, cause, and outcome of reported adverse events.
  • Generate reports based on various safety data and metrics for internal use and regulatory compliance.
  • Collaborate with internal departments and investigative clinical research sites to ensure adherence to safety processes and protocols.

QUALIFICATIONS & EXPERIENCE

Education

  • Bachelor’s degree in a Healthcare-related field (e.g., Nursing, Pharmacy, Pharmacology, etc.) required.

Experience

  • Clinical experience or experience in Clinical Research, including case processing and post-marketing pharmacovigilance is preferred.
  • Previous experience in safety data handling, adverse event reporting, or pharmacovigilance is an advantage.

Skills & Competencies

  • Proficient English communication skills (both written and verbal).
  • Proficient in the use of Microsoft® Office applications.
  • Strong organizational skills with the ability to manage multiple tasks simultaneously.
  • A broad knowledge of medical terminology is essential.
  • Excellent communication and collaboration skills to work effectively with cross-functional teams.

COMPENSATION & BENEFITS

  • Competitive compensation and benefits package.
  • Flexible work environment with opportunities for remote work.
  • Competitive Paid Time Off (PTO) packages.
  • Structured career paths with opportunities for professional growth.
  • Company-sponsored employee appreciation events and recognition programs.
  • Employee health and wellness initiatives.

AWARDS & RECOGNITION

  • Forbes: Recognized as one of America's Most Successful Midsize Companies (2021, 2022, 2023, and 2024).
  • CRO Leadership Awards from Life Science Leader magazine for excellence in expertise, quality, capabilities, reliability, and compatibility.

WHY MEDPACE?

At Medpace, our mission is to accelerate the global development of safe and effective therapeutics. Joining our Clinical Safety team offers the opportunity to make a direct impact on the health and wellbeing of patients worldwide. We are a company of purpose, passion, and people dedicated to making a difference tomorrow by improving lives today.


HOW TO APPLY

Take the next step in your career and apply now to join Medpace as a Clinical Safety Coordinator in Navi Mumbai!