Clinical Safety Manager- Pharmacovigilance / Drug Safety

4-5 years

Not Disclosed

India Mumbai Remote

10 Feb. 12, 2025

Job Description

Job Type: Remote 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 - Pharmacovigilance / Drug Safety
Location: Navi Mumbai, India
Department: Clinical Safety
Job ID: 10602

Job Summary:

Medpace is seeking a full-time Clinical Safety Manager to join its growing Clinical Safety Department in India. The role offers a unique opportunity to utilize your nursing or pharmacovigilance expertise and further develop your career in the pharmacovigilance space. You will play a pivotal role in the safety management process and contribute to the growth of Medpace’s clinical operations.

Responsibilities:

Line Management: Lead, mentor, and develop a team of clinical safety professionals.
Client & Stakeholder Relationship Management: Build and maintain relationships with clients and internal stakeholders, offering expert safety knowledge.
Clinical Safety Case Management: Oversee the management of clinical safety cases and aggregate reporting, ensuring that client needs are met with high quality.
Safety Management Plans: Create and implement safety management plans tailored to client needs.
Safety Review: Provide safety review of clinical study documents, including protocols, study reports, and marketing application components.

Qualifications:

Education: Bachelor’s degree in a healthcare-related field (Nursing, Pharmacy, Pharmacology, etc.).
Experience:
- 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. The company’s mission is to accelerate the global development of safe and effective medical therapeutics with scientific rigor and disciplined approaches. With over 5,000 employees across more than 40 countries, Medpace has a strong global presence.

Why Medpace?

Medpace's mission is centered on improving the lives of patients globally. The work done over the last 30+ years has had a significant impact on numerous lives, and the work done today will continue to positively shape the future for people affected by diseases. By joining Medpace, you will contribute to this meaningful cause.

Medpace Perks:

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

Medpace is committed to creating an inclusive and supportive workplace where your professional development is encouraged. If you’re passionate about making a difference in the lives of patients and looking for a rewarding career in clinical safety, this opportunity is for you!

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Clinical Safety Manager- Pharmacovigilance / Drug Safety

Job Description

Job Summary:

Responsibilities:

Qualifications:

Medpace Overview:

Why Medpace?

Medpace Perks:

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