Instagram
youtube
Facebook

Clinical Safety Manager- Pharmacovigilance / Drug Safety

4+ years
Not Disclosed
10 Dec. 7, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Safety Manager

Location: India
Company: Medpace


About Medpace

Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace employs over 5,000 professionals across 40+ countries. Our mission is to accelerate the global development of safe and effective medical therapeutics through scientific and disciplined methodologies.


Job Overview

Medpace is seeking a Clinical Safety Manager to join our Clinical Safety Department in India. This role is pivotal in the pharmacovigilance process, offering an opportunity to leverage nursing or pharmacovigilance expertise while advancing your career in a dynamic and supportive environment.


Key Responsibilities

  • Team Management:

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

  • Client & Stakeholder Engagement:

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

  • Operational Oversight:

    • Oversee clinical safety case management and aggregate reporting performed by direct reports to ensure high-quality outcomes.

  • Process Development:

    • Develop safety management plans tailored to client needs.

  • Safety Review:

    • Conduct safety reviews of clinical study documents, including protocols, study reports, and marketing application components.


Qualifications

Required:

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

  • At least 4 years of clinical research or pharmacovigilance experience.

  • A minimum of 1 year of clinical nursing experience.

Preferred:

  • Prior project management experience.


Why Join Medpace?

People. Purpose. Passion.

At Medpace, the work we do today makes a difference tomorrow. Our contributions positively impact the lives of countless patients and families, and our commitment to excellence spans all key therapeutic areas.

Employee Benefits:

  • Flexible work environment.

  • Competitive compensation and benefits package.

  • Generous PTO allowances.

  • Structured career paths with growth opportunities.

  • Company-sponsored employee appreciation events.

  • Employee health and wellness initiatives.

Awards and Recognition:

  • Recognized by Forbes as one of America's Most Successful Midsize Companies (2021–2024).

  • Consistently awarded CRO Leadership Awards by Life Science Leader magazine for expertise, quality, reliability, and compatibility.


What’s Next?

A Medpace team member will review your qualifications. If selected, you will be contacted with details on the next steps in the hiring process.


Medpace is an Equal Opportunity Employer and welcomes applications from all qualified individuals, including women, veterans, and individuals with disabilities.