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Clinical Safety Manager- Pharmacovigilance / Drug Safety

4+ years
Not Disclosed
10 Dec. 17, 2024
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: Clinical Safety Manager
Company: Medpace

Job Summary: Medpace is expanding rapidly, and we are currently seeking a Clinical Safety Manager to join our Clinical Safety Department in India. This is an exciting opportunity for those with nursing or pharmacovigilance expertise who are looking to develop and grow their careers in the clinical operations field. As a key member of our pharmacovigilance process, you will play a crucial role in ensuring the safety of clinical trials and managing safety case reporting.

Responsibilities:

  • Manage, mentor, and develop a team of clinical safety professionals.
  • Cultivate and maintain strong relationships with clients and internal stakeholders by providing expert safety knowledge.
  • Oversee clinical safety case management and aggregate reporting responsibilities for direct reports to meet client expectations with high quality.
  • Create safety management plans tailored to client needs.
  • Provide safety review of clinical study documents, including protocols, study reports, and marketing application components.

Qualifications:

  • Bachelor’s degree in a healthcare-related field (Nursing, Pharmacy, Pharmacology, etc.).
  • Minimum of 4 years of clinical research or pharmacovigilance experience.
  • At least 1 year of clinical nursing experience.
  • Prior project management experience is preferred.

Medpace Overview: Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. We leverage local regulatory and therapeutic expertise across all major therapeutic areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs over 5,000 people across more than 40 countries.

Why Medpace?

  • People. Purpose. Passion. Make a difference tomorrow, join us today.
  • The work we’ve done for over 30 years has positively impacted the lives of countless patients and families across key therapeutic areas. The work we continue to do today will improve the lives of people living with illness and disease in the future.

Medpace Perks:

  • Flexible work environment
  • Competitive compensation and benefits package
  • Generous PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives

Awards:

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