Patient Safety Physician or Medical Reviewer | WFH

Jobgether; India; Remote; INR 1.500.000 - 3.600.000; Vollzeit

Benefits dieser Stelle

Fully remote work in India

Full-time permanent

Collaborative pharmacovigilance team

Zusammenfassung

Jobgether is partnering with a client in India to recruit a Patient Safety Physician/Medical Reviewer for a fully remote role. The position requires MBBS with 5+ years of hands-on pharmacovigilance experience, including signal detection and medical review of ICSRs.

You will collaborate with regulatory, clinical, epidemiology, and drug safety teams to ensure compliance with FDA/EMA guidelines and support safety-related decision-making.

Qualifikationen

• MBBS degree mandatory; postgraduate qualifications preferred.
• At least 5 years hands-on experience as Medical Reviewer with signal detection expertise.
• Strong knowledge of pharmacovigilance processes and global drug safety regulations.

Aufgaben

• Perform medical reviews and assessments of ICSRs including seriousness, causality, and clinical relevance.
• Conduct signal detection and evaluation using pharmacovigilance databases and statistical tools.
• Analyze aggregate safety data from trials, post-marketing surveillance, and literature to identify safety trends.
• Prepare and review PSURs, PBRERs, DSURs, and Risk Management Plans.
• Participate in signal management including validation, prioritization, documentation, and escalation.
• Provide medical expertise for benefit-risk assessments of products.
• Monitor safety trends through databases and external sources.
• Collaborate with cross-functional teams to develop risk mitigation strategies.

Kenntnisse

Medical reviewer

Signal detection

Pharmacovigilance

Clinical evaluation

Medical writing

Communication skills

Ausbildung

MBBS

Postgraduate in Pharmacology/Clinical Research/Drug Safety

Tools

Argus

ArisG

Veeva Safety

Empirica Signal

Jobbeschreibung

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Patient Safety Physician or Medical Reviewer | WFH based in India.

Are you an experienced medical professional passionate about patient safety and pharmacovigilance? This remote opportunity offers the chance to play a vital role in protecting patients by evaluating drug safety data and identifying potential risks. You will contribute to signal detection, medical review, and benefit-risk assessments for pharmaceutical products. Working in a dynamic, global environment, you will collaborate with multidisciplinary teams to ensure regulatory compliance and support safety-related decision-making. Your expertise will help shape risk mitigation strategies and maintain the integrity of product safety profiles. This role is ideal for a clinically experienced professional seeking to make a meaningful impact in drug safety and pharmacovigilance.

Accountabilities:

• Perform medical reviews and assessments of Individual Case Safety Reports (ICSRs), including seriousness, causality, expectedness, and clinical relevance.

• Conduct signal detection and evaluation using pharmacovigilance databases and statistical tools, including disproportionality analysis.

• Analyze aggregate safety data from clinical trials, post-marketing surveillance, and scientific literature to identify emerging safety trends.

• Contribute to the preparation and review of Periodic Safety Update Reports (PSURs), Periodic Benefit‑Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).

• Participate in signal management activities, including signal validation, prioritization, documentation, and escalation.

• Provide medical expertise for benefit‑risk assessments of marketed and investigational products.

• Monitor safety trends and emerging risks through pharmacovigilance databases and external sources.

• Collaborate with clinical, regulatory, epidemiology, and drug safety teams to evaluate signals and develop risk mitigation strategies.

• Ensure compliance with global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH E2E, ICH E2D, and GVP Modules.

• Contribute to SOP development, safety governance meetings, and safety review committees.

• Support responses to health authority queries and contribute to safety audits and inspections.

Requirements:

• MBBS degree is mandatory; postgraduate qualifications in Pharmacology, Clinical Research, or Drug Safety are preferred.

• At least 5 years of hands‑on experience as a Medical Reviewer, with demonstrated expertise in signal detection and evaluation.

• Strong knowledge of pharmacovigilance processes, signal detection methodologies, and global drug safety regulations.

• Proficiency in safety databases such as Argus, ArisG, Veeva Safety, or similar platforms.

• Experience with disproportionality analysis and signal detection tools such as Empirica Signal.

• In‑depth understanding of global pharmacovigilance regulations, including ICH E2E, ICH E2D, and GVP Modules.

• Strong clinical evaluation, medical writing, analytical, and decision‑making skills.

• Excellent communication, presentation, and interpersonal abilities.

• Effective cross‑cultural communication and collaboration skills.

• Strong critical thinking, problem‑solving, and clinical judgment.

• Ability to manage priorities, maintain accurate documentation, and consistently meet deadlines.

Benefits:

• Work arrangement: Fully remote, work-from-home opportunity in India.

• Employment type: Full‑time, permanent position.

• Location: Mumbai, Maharashtra, India, with remote working flexibility.

• Salary: Compensation based on previous CTC and experience.

• Notice period: Open to candidates with any notice period.

• Career impact: Opportunity to contribute to global patient safety and pharmaceutical risk management.

• Professional environment: Collaboration with multidisciplinary teams across pharmacovigilance, clinical research, and regulatory affairs.

We appreciate your interest and wish you the best!