Position Code: DSP001
Location: Chandigarh
Job Type: Full-time
Department: Pharmacovigilance
About the Role:
Drug Safety Physician: We are looking for a qualified and experienced Drug Safety Physician to join our Pharmacovigilance team in Chandigarh. The selected candidate will play a key role in analyzing, evaluating, and reporting drug safety data for both investigational and marketed products. This includes preparing periodic regulatory reports, conducting signal detection, performing medical review of safety data, and supporting global regulatory compliance.
Key Responsibilities:
- Preparation of periodic safety and benefit-risk evaluation reports such as:
- PBRERs (Periodic Benefit-Risk Evaluation Reports)
- PSURs (Periodic Safety Update Reports)
- Addendum to Clinical Overviews (ACOs)
- Addendum PSURs and PSUR Line Listings
- US PADERs (Periodic Adverse Drug Experience Reports)
- Conducting quality checks of aggregate reports
- Performing signal detection-related analyses including:
- Cumulative data analysis
- Issue event analyses
- Signal Evaluation and Drug Safety Reports
- Literature review and case listing assessments
- Vigilance and monitoring of important/designated medical events
- Interaction with clients for signal discussion, issue resolution, and regulatory communication
- Support in preparation and maintenance of Risk Management Plans (RMPs)
- Performing medical review of:
- Individual Case Safety Reports (ICSRs)
- Clinical Study Report (CSR) narratives
- Providing medical expertise to drug safety scientists
- Maintaining knowledge of drug safety profiles, labeling documents, and SOPs
- Ensuring compliance with global regulatory timelines and reporting standards
- Maintaining accurate records in line with company guidelines and SOPs
Minimum Qualifications:
- MBBS or MD (preferably in a clinical specialty)
- Strong capability to interpret medical and scientific data
- Excellent skills in writing clear, concise, and accurate medical documentation
- Ability to evaluate and synthesize clinical and safety data independently
- Fluent in written and spoken English
- Proficient in computer systems: Windows 10/7, MS Office Suite (Word, Excel, PowerPoint), and web-based applications
- High level of attention to detail, transcription accuracy, and data quality
Important Note:
Candidates with qualifications in Ayurveda, Homeopathy, Veterinary Sciences, or other alternative medicine streams, or those with only Life Sciences degrees (non-MBBS/MD) are not eligible for this position.
How to Apply:
Interested and eligible candidates are requested to fill out the application form provided on the website and submit their updated resume along with relevant documents.
Why Join Us?
- Work with a dedicated pharmacovigilance and regulatory team
- Opportunity to contribute to global drug safety initiatives
- Collaborative and growth-oriented environment
- Continuous learning and development
If you have the medical background, analytical mindset, and passion for drug safety, we encourage you to apply and become part of our growing team.