Drug Safety Physician
About the Role
Company Overview
Continuum India is an emerging and rapidly growing CRO that operates from Chandigarh and provides solutions for pharmacovigilance, regulatory affairs, and clinical and technology services. The organization provides solutions at every stage of the product lifecycle including those for pharmaceuticals, medical devices, and consumer healthcare.
Safety, quality, and regulatory compliance is ensured by Continuum India owing to their deep domain expertise and technology-driven solutions. Multidisciplinary teams at the organization include doctors and life scientists who provide decades of experience in providing data-driven insights for different treatment categories.
The organization is highly regarded by global healthcare organizations for its innovation and responsive and excellent operations. The mission of Continuum India is geared towards improving healthcare through research and development.
Job Role
The Drug Safety Physician plays an important part in ensuring the safety and effectiveness of pharmaceutical products through conducting thorough medical evaluation of safety information. This involves evaluating adverse event reports, and participating in the preparation of aggregate safety documents. the role also involves signal management in accordance with international guidelines and customer specifications. It requires good clinical knowledge along with analytical skills.
Job Summary
The key responsibilities of the Drug Safety Physician would include conducting medical assessments for ICSR, preparation and review of aggregate safety reports and involvement in signal detection and assessment process. They would be working together with the pharmacovigilance department in order to provide proper reporting of the drug safety information in a proper and timely manner. Besides, their responsibilities would also include reviewing safety narratives from clinical trials and interpretation of medical data.
Key Responsibilities
Conduct comprehensive medical review of ICSR’s for both marketed and investigational products, with accuracy in determination of seriousness, causality and expectedness.
Support the preparation and conduct medical review of periodic safety reporting documentation like Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), Risk Management Plan (RMP), and other documentation.
Provide medical support to Pharmacovigilance Scientists in the evaluation of cases.
Prepare and review Analysis of Similar Events (AOSE) for Serious and Unexpected adverse reactions.
Undertake signal management tasks such as signal detection, signal validation, signal prioritization, and medical assessment.
Undertake searches of scientific literature, including journals and abstracts, for safety issues.
Perform evaluation of safety case listing, which includes deaths, pediatric and geriatric cases, pregnant cases, and cases of inefficacy.
Perform a comprehensive medical review of safety narratives documented in Clinical Study Reports (CSR).
Coordinate with other internal as well as external parties to address concerns regarding the quality of deliverables.
Perform activities related to audit and inspection readiness in accordance with the regulatory requirements.
Mentor junior physicians and facilitate information exchange amongst the members.
Recognize any potential hazards or inefficiencies within processes and report them to the project management.
Have current knowledge about drug safety regulations, safety profile of the product, and label information.
Qualification and Education Needed
MBBS is mandatory.
An MD is preferred and considered an added advantage.
Knowledge of pharmacovigilance and global drug safety regulations.
Familiarity with medical terminology and clinical data interpretation.
Skills and Personal Attributes
Excellent analytical and clinical judgment.
Ability to interpret complicated medical information.
Keen eye for detail.
Proficient in spoken and written English.
Able to juggle multiple projects with ease and meet deadlines.
Experience with MS Word, Excel, etc., and web-based tools.
Highly cooperative in team and can work individually.
Able to solve problems proactively.
Adaptable to global business culture.
Highly accurate in documentation, typing and transcription tasks.
Salary and Benefits
The pay structure for this position is competitive and as per industry standards. The salary range for this job role is INR 11-13 LPA. Negotiations are welcomes based on the experience and qualifications of the candidate. Besides the base pay, there is:
Incentives based on performance
Health care coverage
Paid vacation days
Training opportunities
Importance of the Role
The Drug Safety Physician plays an important part in preserving public health through monitoring pharmaceutical products for safety on a regular basis. The function helps in meeting the needs of health agencies all around the world through the proper evaluation of adverse events and contributing to regulatory submissions. The responsibilities of this physician have a direct influence on patient safety and pharmacovigilance activities of the company.
Career Progression Opportunities
This job role provides plenty of scope for professional development in the field of pharmacovigilance and clinical research. Based on experience, one can progress to higher roles like that of:
Senior Drug Safety Physician
Medical Reviewer Lead
Pharmacovigilance Manager
Knowledge of international regulatory systems and different areas of therapy is valuable when it comes to career development in industries and consultancies.
How to Apply
Interested candidates who meet the above qualifications are encouraged to apply through Jobslly:
Create your account on Jobslly.
Search for job Drug Safety Physician/ Continuum India
Upload your resume.
Include a cover letter to explain your interest.
Upload any relevant certifications or courses.
Submit the completed application.
Shortlisted candidates will be contacted for further evaluation, which may include interviews and technical assessments.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.