Clinical Study Scientist

Gratitude Inc

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1 month ago

Clinical Study Scientist

5-12 Year(s)

90 - 130 Thousand p.m

Bangalore

Job Description

Key Skills

Clinical research Project management International BPO Clinical Authorization Aggregate Reports Signal Management Knowledge of relevant regulatory & scientific guidelines Life science graduate

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Job Posting: Clinical Safety Scientist

Job Code: 374082

Location: Mumbai/Bangalore/Noida

Shift: General Shift

Band: BPO 4/5

Salary Range: 11 - 16 LPA

Educational Qualification: Any Life Science graduate (excluding B.Pharm)

Key Requirements:

The candidate must be currently located in Mumbai, Bangalore, or Noida.

Graduation is compulsory.

International BPO experience is required.

Required Technical Skill Set:

Literature review:

Aggregate Reports:

Signal Management:

Project Management:

General Knowledge and Skills:

Knowledge of relevant regulatory & scientific guidelines.

Ability to present/communicate effectively with stakeholders on safety topics.

Ability to speak up effectively and ensure that questions and uncertainties are addressed, or negotiate/adapt the plan for the work.

Knowledge across the responsibilities of relevant stakeholders and processes.

Ability to work in a team with different stakeholders.

Prioritise and delegate tasks based on the importance of the deliverables and awareness of overall timelines.

Providing training with respect to the medical aspects of drug safety to various stakeholders.

Attending and presenting at medical scientific conferences or publishing [optional, outside of the scope of responsibilities].

Responsibilities and Expectations:

Provide mentorship, oversight, and training of less experienced colleagues.

Have a good understanding of all in-scope processes.

Contribute to all signal management activities with medical expertise, i.e., contribute to detection, validation, DSR strategy, and SME review; from time to time, author parts of DSRs (e.g., conclusion).

Confidently participate in report kick-off meetings and other meetings, as necessary.

Review of Clinical Study Reports (CSRs) safety sections and narratives for CSRs or health authority requests.

Provide expert medical input to aggregate reports and other processes.

Support Health Authority requests with medical expertise, including review and authoring of critical parts as/if necessary.

Lead or contribute to process improvement and technology/innovation activities.

Participate in internal and external audits and inspections, as required.

Expectations of Working in a Matrix Model:

Take proactive ownership of delegated molecule safety activities, contributing to ensuring patient safety and the molecule’s safety strategy, i.e., proactive suggestions for SRP, DSR strategy, and addressing SRR topics.

Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)/deliverables.

Consistently delivering quality the first time across processes.

Showing a thorough understanding and competency in how the different pharmacovigilance processes connect.

Excellent collaboration and leadership with cross-functional safety teams.

Independence, ownership, and high competence in the conduct of all Clinical safety science responsibilities.

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Role

Clinical Research Associate/Scientist

Timings

Rotational Shifts (Permanent)

Industry

BPO

Work Mode

Work from office

Functional Area

Medical Professional / Healthcare Practitioner / Technician

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