Mdr/Vigilance Specialist

2+ years

Not Disclosed

Hyderabad

10 July 26, 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, 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

Join Medtronic: Pioneering Healthcare Innovation and Access

A Day in the Life

As a key member of our team, you'll engage in a dynamic role that includes the following responsibilities and more:

Oversee the company’s drug and medical device surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
Ensure accurate and complete maintenance of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, and adverse reaction data in compliance with regulatory agencies.
Review and analyze clinical databases to extract ADE data, integrating it to create a unified database that aligns with ADE standardization and internalization goals, ensuring the accuracy and quality of safety summaries.
Act as a liaison with internal teams and external collaborators to develop programs and processes that meet regulatory reporting requirements.

Specialist Career Stream

Role: An individual contributor with expertise in a specialized discipline or field. Manage projects from design to implementation, adhering to policies and utilizing advanced education and experience.
Autonomy: Operate independently with general supervision on larger, moderately complex projects.
Organizational Impact: Set objectives for your role to meet project goals and contribute to project milestones.
Innovation and Complexity: Address general problems and issues with a focus on improving systems and processes. Recommendations for enhancements are part of the role.
Communication and Influence: Engage primarily with internal contacts. External interactions involve sharing information and supporting decision-making.
Leadership and Talent Management: Provide guidance to entry-level professionals or employees in support roles.

Required Knowledge and Experience

Education: Bachelor’s degree or equivalent international degree as per 8 C.F.R. § 214.2(h)(4)(iii)(A). Advanced degree with no additional experience required.
Experience: Minimum of 2 years of relevant experience or advanced degree with no experience required.
Skills: Practical knowledge and demonstrated competence in the job area, typically obtained through advanced education and experience.

Physical Job Requirements

The role involves performing general duties related to the job, with responsibilities and skills that are not exhaustive but provide a clear understanding of the position’s scope.

Benefits & Compensation

Medtronic offers a competitive salary and a flexible benefits package. Our commitment to our employees is central to our values. We recognize and reward their contributions and provide a wide range of benefits and resources designed to support them throughout their career and life stages.

About Medtronic

At Medtronic, we lead global healthcare technology and tackle the most challenging health problems with innovative solutions. Our mission—to alleviate pain, restore health, and extend life—unites a passionate global team of over 90,000 individuals. We are driven by a commitment to engineering extraordinary solutions, from the R&D lab to the factory floor to the conference room. We embrace talent, diverse perspectives, and the courage to create real, impactful solutions.

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Mdr/Vigilance Specialist

Job Description

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