Medical Consultant – Pharmacovigilance Physician
Thermo Fisher Scientific | PPD Clinical Research Services
Location: Hyderabad, Andhra Pradesh, India
Job Type: Full-Time
Work Mode: Fully Remote
Shift: Third Shift / Night Shift
Industry: Clinical Research | Pharmacovigilance | Drug Safety | CRO
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in scientific innovation, clinical research, and healthcare advancement. Through its renowned PPD Clinical Research portfolio, the organization supports pharmaceutical, biotechnology, and healthcare companies in accelerating drug development, clinical trials, and pharmacovigilance operations across more than 100 countries.
With experience supporting the world’s top pharmaceutical companies and over 2,700 clinical trials globally, Thermo Fisher Scientific continues to transform patient safety, drug monitoring, and clinical research excellence.
Job Overview – Medical Consultant / Pharmacovigilance Physician
Thermo Fisher Scientific is hiring experienced Medical Consultants and Pharmacovigilance Physicians for its global clinical research and drug safety operations team. This opportunity is ideal for medical professionals with expertise in pharmacovigilance, clinical safety, ICSR review, signal detection, aggregate reporting, and regulatory compliance.
The selected candidate will provide medical oversight for pharmacovigilance activities, ensuring adherence to global regulatory requirements, company SOPs, ICH-GCP guidelines, and client-specific safety procedures.
This role involves medical review of serious adverse events (SAEs), adverse events of special interest (AESIs), causality assessment, expectedness evaluation, MedDRA coding review, signal management, risk-benefit analysis, and preparation of aggregate safety reports including PSUR, PBRER, and DSUR.
Experience Required
MBBS with minimum 2 years of clinical experience
OR
MD / Equivalent medical qualification with relevant clinical or pharmacovigilance exposure
Experience Level:
Experienced Professionals Preferred
Candidates with prior experience in Pharmacovigilance, Drug Safety, Clinical Research Organizations (CROs), Pharmaceutical Companies, or Clinical Practice are highly preferred.
Key Responsibilities
Pharmacovigilance & Drug Safety Activities
Perform medical review and analysis of Individual Case Safety Reports (ICSRs)
Review Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Conduct causality assessment, seriousness determination, and expectedness evaluation
Support signal detection and benefit-risk assessment activities
Ensure compliance with FDA, EMA, ICH-GCP, and global pharmacovigilance regulations
Aggregate Reporting & Regulatory Documentation
Contribute to preparation and scientific review of:
PSUR
PBRER
DSUR
Risk Management Plans (RMP)
REMS documentation
Clinical Study Reports (CSR)
CTD Modules
IND/NDA safety sections
Medical Oversight & Consultation
Provide pharmacovigilance consultation to project teams and sponsors
Participate in sponsor meetings and client discussions
Deliver therapeutic area and protocol-specific training
Support medical review of safety data from clinical trials and post-marketing sources
Data Review & Safety Surveillance
Review safety databases and coding listings
Evaluate literature safety reports and spontaneous adverse event reports
Identify potential safety concerns and emerging signals
Support dossier maintenance and labeling updates
Educational Qualification
Mandatory Qualification
MBBS with minimum 2 years clinical experience
OR
MD / Equivalent Medical Degree
Preferred
Active medical license preferred
Experience in Pharmacovigilance or Clinical Research preferred
Required Skills
Strong understanding of Pharmacovigilance and Drug Safety operations
Expertise in MedDRA coding and safety terminology
Knowledge of ICH Guidelines, FDA Regulations, EMA Guidelines, and GCP
Understanding of signal detection and benefit-risk evaluation
Experience with safety databases and clinical safety review
Excellent communication, presentation, and analytical skills
Strong documentation and medical writing capabilities
Ability to work independently in global cross-functional teams
Why Join Thermo Fisher Scientific?
Work with one of the world’s leading Clinical Research Organizations (CROs)
Gain global exposure in pharmacovigilance and clinical safety operations
Opportunity to work on international clinical trials and innovative therapies
Collaborative work culture focused on scientific excellence and career growth
Remote work flexibility with global project experience
Who Should Apply?
This opportunity is ideal for:
MBBS Graduates interested in Pharmacovigilance careers
MD Professionals seeking global drug safety exposure
Clinical Research professionals transitioning into Pharmacovigilance
Drug Safety Associates aiming for medical review and physician roles
Healthcare professionals with experience in clinical trials and regulatory safety
Keywords for Job Seekers
Pharmacovigilance Jobs in Hyderabad, Medical Consultant Jobs India, Drug Safety Physician Jobs, Remote Pharmacovigilance Jobs, ICSR Review Jobs, Aggregate Reporting Jobs, Clinical Research Jobs India, CRO Jobs Hyderabad, SAE Review Jobs, Signal Detection Jobs, MBBS Pharmacovigilance Careers, MD Drug Safety Jobs, PSUR PBRER DSUR Jobs, Thermo Fisher Scientific Careers, PPD Pharmacovigilance Jobs
Apply Now
Candidates interested in advancing their career in Pharmacovigilance, Clinical Research, Drug Safety, and Regulatory Medical Review are encouraged to apply for this exciting global opportunity with Thermo Fisher Scientific.
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