Mdr/Vigilance Specialist

2+ years

Not Disclosed

Hyderabad

10 Aug. 6, 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

Begin Your Career in Innovation and Healthcare Advocacy at Medtronic

At Medtronic, embark on a life-long journey of exploration and innovation while championing healthcare access and equity for all. Lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life: Responsibilities

Surveillance Program Monitoring: Oversee the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports. Participate in resolving legal liabilities and ensure compliance with government regulations.
Regulatory Reporting: Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
Data Analysis and Integration: Review and analyze clinical databases to extract ADE data, integrating it to create a unified database. Ensure the accuracy and quality of safety summaries.
Liaison Role: Act as a liaison internally and with external collaborators to develop programs and processes that meet regulatory reporting requirements.

Specialist Career Stream

Role Description: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or direct the work of lower-level professionals. The majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies, using specialized knowledge and skills typically acquired through advanced education.

Differentiating Factors

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects or assignments.
Organizational Impact: Sets objectives for own job area to meet project objectives. Contributes to the completion of project milestones and may have some involvement in cross-functional assignments.
Innovation and Complexity: Faces general problems and issues that may require understanding broader sets of issues or other job areas but are typically not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness.
Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Shares information, status, needs, and issues to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and employees in the Support Career Stream.

Required Knowledge and Experience

Education: Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)).
Experience: Minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
Skills: Practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.

Physical Job Requirements

The above statements describe the general nature and level of work being performed by employees assigned to this position but are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package. Our commitment to our employees lives at the core of our values. We recognize their contributions and share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology, boldly addressing the most challenging health problems by finding innovative solutions. Our mission—to alleviate pain, restore health, and extend life—unites a global team of over 90,000 passionate individuals. As engineers at heart, we turn ambitious ideas into real solutions for real people, from the R&D lab to the factory floor to the conference room. With diverse perspectives and a fearless approach, we engineer the extraordinary.

Learn more about our business, mission, and commitment to diversity here.

Medtronic is an equal opportunity employer committed to fostering an inclusive and diverse workplace.

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Mdr/Vigilance Specialist

Job Description

Begin Your Career in Innovation and Healthcare Advocacy at Medtronic

A Day in the Life: Responsibilities

Specialist Career Stream

Differentiating Factors

Required Knowledge and Experience

Physical Job Requirements

Benefits & Compensation

About Medtronic

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