Pharmacovigilance Specialist (Post Market Surveillance and Vigilance Specialist)
Pharmacovigilance Specialist (Post Market Surveillance and Vigilance Specialist)
Enovis
Job description
Looking to build a career in medical device post-market surveillance? Explore this PV Specialist (Post-Market Surveillance and Vigilance Specialist) role at Enovis in Hyderabad.
Company Description
Enovis is a medical technology company that is driven by innovation. It focuses on developing solutions that help patients do better and make work easier. Enovis works in orthopedics and many other areas, using constant improvement, talent from all over the world, and fresh ideas. The company brings together products, services, and technology to help people stay active all over the world. Enovis keeps working to deliver results for patients, teams, and shareholders.
Job Summary
This fully remote role sits within Regulatory Affairs, Surgical International, based in Hyderabad. As a Pharmacovigilance Specialist (post-market surveillance and vigilance specialist), you will help with surveillance and vigilance efforts for medical devices that are sold all over the world. Your job will involve dealing with complaints, making reports, and watching for trends. The position also requires working with the Regulatory Affairs, Quality, Clinical Affairs, Risk Management, and Manufacturing teams.
Key Responsibilities
Perform intake, review, and data entry of product complaints in the complaint system.
Check each complaint for completeness. Reach out for missing information when needed.
Perform initial triage and categorize complaints, following set procedures.
Help with complaint follow-up tasks to make sure each case is closed on time.
Keep records of complaints that follow quality rules.
Prepare and maintain vigilance and adverse event reports for regulatory authorities.
Maintain documentation supporting regulatory reporting decisions.
Collect and analyze post-market surveillance data from multiple sources.
Generate PMS metrics, dashboards, and periodic reports for management review.
Support the preparation of PMS reports and Periodic Safety Update Reports.
Monitor data and identify opportunities for process improvement.
Support benefit-risk evaluation activities through data analysis.
Perform complaint trending and statistical checks to identify safety signals.
Support escalation of adverse trends that need further investigation.
Work with cross-functional teams to evaluate trend outcomes and next steps.
Support Health Hazard Evaluation activities through data gathering and documentation.
Support the review and update of PMS and Vigilance SOPs and forms.
Educational Qualification
Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Quality, Regulatory Affairs, or a related scientific field.
Advanced degrees are considered an advantage.
Skills Required
1 - 3 years of experience in the medical device or healthcare industry.
Experience in complaint handling, vigilance, regulatory affairs, or quality systems is preferred.
Familiarity with EU MDR, FDA Medical Device Reporting, and ISO 13485 is required.
A good understanding of post market surveillance and complaint handling processes is essential.
Experience using tools such as Agile PLM, Power BI, or Excel is a plus.
Strong analytical skills and strong problem-solving skills are necessary.
Written and verbal English communication skills are essential.
Salary Structure
The Pharmacovigilance Specialist (Post Market Surveillance & Vigilance Specialist) role at Enovis in India has an estimated salary range of ₹4 Lakhs to ₹7 Lakhs per year.
Career Development
This role offers strong exposure to global post-market surveillance work within a growing medical technology company. Enovis also supports long-term growth through a comprehensive benefits package and opportunities to build deeper expertise in regulatory and quality functions.
How to Apply
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Education
Bachelor's Degree
Key Skills
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.