Life Science : Medical Reviewer : PV : Clinical Case Study : MBBS / MD (Bengaluru)

Life Science : Medical Reviewer : PV : Clinical Case Study : MBBS / MD (Bengaluru)

04 Aug
|
Outpace Consulting Services
|
Bengaluru

04 Aug

Outpace Consulting Services

Bengaluru

Hi,

We are hiring for one of Indias leading IT & consulting organizations for the position of Medical Reviewer.

Please go through the JD and Apply. We shall call back the relevant profiles.

- To Apply for above Medical Reviewer, WhatsApp 'Hi' @ (phone hidden)
- When Asked For The job Code, Type: Job Code # 1

Key Skills :

1. Minimum 1 year of experience in Pharmacovigilance / Drug Safety / Medical Review
2. Perform medical review of adverse event cases (ICSRs) from global safety databases
3. Graduate in MBBS or MD degree (mandatory)

:

- Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including labeling and causality along with the company causality statement)
- Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history
- Developing and maintaining thorough knowledge of the appropriate disease biology areas C important safety concerns for marketed drugs and drugs in development
- Assuring and maintaining compliance with regulatory and local/global SOP timelines




- Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing
- Representing safety physician team in internal and client safety forums and audits
- Review and respond to any queries/comments for an individual case safety report in the Patient Safety database.
- Responsible for generating, sending, and tracking medically relevant queries for follow-up information that is required for an individual case safety report
- Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Responsible Adverse reaction (SUSAR)
- Ensure compliance with global and local procedural documents and implementation of client, policies, procedures, and processes.

Skills required:

- Aptitude for self-directed learning
- Good medical knowledge and its application in drug safety
- Sound understanding of the Drug Safety and Regulatory process
- Good problem solving and decision-making skills
- Initiative-taking, able to prioritize and plan effectively
- Excellent interpersonal and communication skills
- Team player with ability to function in a multi disciplinary workplace

📌 Life Science : Medical Reviewer : PV : Clinical Case Study : MBBS / MD (Bengaluru)
🏢 Outpace Consulting Services
📍 Bengaluru

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