Associate Medical Safety Director Remote Job at IQVIA in Thane for medical professionals with pharmacovigilance experience and clinical trial safety expertise.
The pharmaceutical and clinical research industry depends on strong pharmacovigilance systems to monitor drug safety and protect patient health throughout the drug development lifecycle. Medical safety professionals play a crucial role in evaluating adverse events, assessing benefit–risk profiles, and ensuring regulatory compliance across clinical trials and post-marketing surveillance activities.
IQVIA is currently hiring for the position of Associate Medical Safety Director in Thane, India, with a home-based work model. This role is designed for qualified medical professionals who can provide clinical expertise in drug safety evaluation, pharmacovigilance case review, and regulatory safety reporting.
The selected candidate will contribute to safety oversight for clinical trials and post-marketing projects, working closely with global pharmacovigilance teams, clinical research professionals, and regulatory stakeholders. Associate Medical Safety Director Remote Job at IQVIA
Company Overview
IQVIA is a global leader in clinical research services, healthcare analytics, and life sciences technology solutions. The organization works with pharmaceutical, biotechnology, and healthcare companies worldwide to accelerate the development and commercialization of innovative therapies.
By integrating clinical expertise, advanced analytics, and healthcare intelligence, IQVIA helps companies optimize drug development processes and improve patient outcomes. The company supports clinical trials, pharmacovigilance operations, regulatory activities, and real-world evidence generation across multiple global markets.
Professionals working at IQVIA gain exposure to international clinical research projects and global drug safety programs, contributing to the development of safe and effective medicines. Associate Medical Safety Director Remote Job at IQVIA
Job Overview (Job Details)
| Job Title | Associate Medical Safety Director |
|---|---|
| Company | IQVIA |
| Department | Pharmacovigilance / Medical Safety |
| Job Location | Thane, Maharashtra, India |
| Work Mode | Home-Based / Remote |
| Employment Type | Full-Time |
| Qualification | Medical Degree (MBBS or equivalent) |
| Experience Required | Clinical Practice + Pharmaceutical Industry Experience |
| Industry | Clinical Research / CRO / Pharmacovigilance |
| Application Mode | Online Application |
Job Location & Employment Type
- Location: Thane, Maharashtra, India
- Work Model: Home-Based / Remote
- Employment Type: Full-Time
- Department: Pharmacovigilance / Medical Safety
This role focuses on providing medical oversight for drug safety monitoring and pharmacovigilance activities across clinical and post-marketing projects. Associate Medical Safety Director Remote Job at IQVIA
Open Position
Associate Medical Safety Director
The selected candidate will support medical safety functions by reviewing adverse events, evaluating clinical safety data, and ensuring regulatory compliance in pharmacovigilance operations. Associate Medical Safety Director Remote Job at IQVIA
Key Roles & Responsibilities
Professionals selected for this role will perform multiple responsibilities related to medical safety monitoring and pharmacovigilance oversight. Associate Medical Safety Director Remote Job at IQVIA
Adverse Event Review and Safety Evaluation
- Conduct medical review of clinical trial adverse events (AEs) and post-marketing adverse drug reactions (ADRs).
- Assess case narratives, seriousness, expectedness, causality, and medical coding accuracy.
- Provide clinical clarification and expert medical opinion during case processing.
Safety Signal Analysis
- Prepare and review Analyses of Similar Events (AOSE) for expedited safety cases.
- Evaluate safety signals and maintain oversight of product safety profiles.
Pharmacovigilance Team Support
- Act as an internal medical consultant to pharmacovigilance case processing teams.
- Provide clinical guidance on safety assessments and regulatory reporting.
Aggregate Safety Data Review
- Review clinical safety data and aggregate reports to assess overall product safety trends.
- Support safety monitoring activities throughout clinical development.
Clinical Data Coding Review
- Perform medical review of clinical data listings including:
- Adverse events
- Past medical history
- Concomitant medications
- Ensure accurate medical coding and data interpretation.
Regulatory Safety Reporting
- Provide medical review and edits for regulatory safety reports, including:
- IND Annual Reports
- Periodic Benefit–Risk Evaluation Reports (PBRER)
- Periodic Safety Update Reports (PSUR)
- Development Safety Update Reports (DSUR)
Risk Management Documentation
- Contribute to development and review of:
- Risk Management Plans (RMP)
- Risk Evaluation and Mitigation Strategies (REMS)
- Development Risk Management Plans
Labeling and Safety Documentation
- Provide medical oversight for product labeling updates.
- Contribute to safety sections of regulatory documents and clinical reports.
Safety Committee Participation
- Attend Data Safety Monitoring Board (DSMB) meetings.
- Participate in Safety Monitoring Committees and clinical safety review discussions.
Regulatory Documentation Support
- Contribute to preparation of Integrated Safety Summaries and Common Technical Documents (CTD).
- Review benefit-risk assessments and drug safety reports.
Clinical Study Safety Oversight
- Review and approve safety-related study documents such as:
- Project Safety Plans
- Medical Monitoring Plans
- Study Protocols
- Investigational Drug Brochures (IDB)
- Case Report Forms (CRFs)
Global Safety Project Participation
- Act as Global Safety Physician or backup physician on assigned projects.
- Attend project meetings, safety team meetings, and sponsor discussions.
Regulatory Compliance and Monitoring
- Ensure safety deliverables meet regulatory timelines and contractual requirements.
- Stay updated with global medical safety and pharmacovigilance regulations.
Associate Medical Safety Director Remote Job at IQVIA
Eligibility Criteria
Candidates interested in applying for this role should meet the following requirements.
Education
Applicants must possess:
- Medical Degree (MBBS or equivalent)
from a recognized and accredited medical school.
Associate Medical Safety Director Remote Job at IQVIA
Experience
Candidates should have:
- Minimum 3 years of clinical practice experience (such as postgraduate medical training)
and
- At least 2 years of experience in the pharmaceutical or related healthcare industry
Equivalent combinations of education, training, and experience may also be considered. Associate Medical Safety Director Remote Job at IQVIA
Skills Required
Applicants should possess the following professional and technical skills:
- Strong knowledge of pharmacovigilance and drug safety systems
- Understanding of clinical trials and drug development lifecycle
- Familiarity with Good Clinical Practice (GCP) guidelines
- Knowledge of global pharmacovigilance regulations
- Ability to analyze complex clinical safety data
- Strong decision-making and clinical judgment skills
- Effective communication and collaboration abilities
- Ability to manage multiple projects and deadlines
Salary & Benefits
Salary for this position will be as per company norms and industry standards.
Additional benefits may include:
- Work-from-home flexibility
- Exposure to global pharmacovigilance programs
- Career growth opportunities in medical safety leadership roles
- Participation in international clinical research projects
- Professional development and training programs
Selection Process
The recruitment process for this role may include:
- Resume screening and application review
- Technical interview focusing on pharmacovigilance and medical safety knowledge
- HR interview and final evaluation
- Job offer and onboarding process
Only shortlisted candidates will be contacted by the recruitment team. Associate Medical Safety Director Remote Job at IQVIA
How to Apply
Interested candidates should apply through the official IQVIA careers portal.
Applicants should ensure their resume highlights experience in:
- Pharmacovigilance
- Medical safety evaluation
- Clinical research
- Drug safety reporting
Important Dates
- Job Posted: Recently announced
- Application Deadline: Not specified
Candidates are encouraged to apply early as the position may close once suitable candidates are selected.
Why Apply for This Pharma Job?
This role provides an excellent opportunity for medical professionals interested in pharmacovigilance and clinical safety leadership.
Key benefits include:
- Opportunity to work with a global clinical research organization
- Exposure to international drug safety and pharmacovigilance programs
- Participation in clinical trial safety monitoring
- Career advancement in medical safety leadership roles
- Opportunity to contribute to safer medicines and improved patient outcomes
Professionals seeking to build a career in pharmacovigilance, clinical safety, and regulatory medical affairs will find this opportunity highly valuable. Associate Medical Safety Director Remote Job at IQVIA
Important Note
IndiaPharmaJobs.in is an independent job information platform that publishes pharmaceutical and clinical research job updates for informational purposes only.
We are not affiliated with any company mentioned in this article and do not charge any fee for job applications. Candidates should always apply through official company recruitment channels. Associate Medical Safety Director Remote Job at IQVIA
Final Call-to-Action
If you are a qualified medical professional with experience in pharmacovigilance or clinical research safety, this opportunity with IQVIA can help advance your career in global drug safety operations. Eligible candidates are encouraged to apply online and explore this leadership role in medical safety. Associate Medical Safety Director Remote Job at IQVIA
