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Clinical Safety Manager - Pharmacovigilance / Drug Safety

4+ years years
upto 9 LPA
5 July 17, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Safety Manager - Pharmacovigilance / Drug Safety

Location: Navi Mumbai, India
Department: Clinical Safety
Job Code: 10023

 

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time Clinical Safety Manager to join our Clinical Safety Department in India. This position plays a key role in the pharmacovigilance process at Medpace. If you want an exciting career where you can use your nursing or pharmacovigilance expertise and develop and grow your career even further, then this is the opportunity for you.

 

Responsibilities

  • Line manage, mentor, and develop a team of clinical safety professionals

  • Manage relationships with clients and internal stakeholders by providing expert safety knowledge

  • Oversee clinical safety case management and aggregate reporting responsibilities of direct reports to ensure client needs are fulfilled to high quality

  • Create safety management plans dependent upon client requirements

  • 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.)

  • At least 4 years of clinical research/pharmacovigilance experience

  • At least one year of clinical nursing experience

  • Prior project management experience is preferred

 

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 5,000 people across 40+ countries.

 

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families facing hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

 

Medpace Perks

  • Hybrid work-from-home options (dependent upon position and level)

  • Competitive PTO packages

  • Company-sponsored employee appreciation events

  • Employee health and wellness initiatives

  • Flexible work schedule

  • Competitive compensation and benefits package

  • Structured career paths with opportunities for professional growth

 

Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024

  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility