Drug Safety Assistant
About the Role
Company Overview
ProPharma Group leads a globally harmonized group of Companies dedicated to regulatory, clinical, and pharmacovigilance services for 20+ years. They partner with pharmaceutical and medical device companies and promote drug development from the earliest stages until bringing patients to safety. The broad portfolio of ProPharma’s global, comprehensive and seamlessly interconnected solutions covers the entire product lifecycle, including regulatory services, clinical trials, quality and compliance, and drug safety operations.
The emphasis ProPharma puts on innovation and compliance ensures clients are bringing to market important life-saving treatments, keeping the ultimate standards of compliance & safety.
ProPharma creates an inclusive work atmosphere where employees develop in-depth experience in pharmacovigilance.
Job Summary
The drug safety assistant facilitates ongoing pharmacovigilance activities, including AE and PQC follow-up. Activities include the collection of safety-related documents, status tracking of cases and communication to and between business areas and the client. Key activities of the Drug Safety Assistant involve managing safety documents and follow-up status of product quality complaints, processing of AEs as per protocol to allow effective and in-time review.
They have the ability to work in a fast-paced environment with a high level of detail and can manage multiple assignments effectively.
Key Responsibilities
Assist with jobs related to negative occurrences and quality control of goods by providing help with the administration. Offer appropriate advice regarding important documentation and processes concerning safety.
Prepare communication regarding matters of safety. This can include writing letters and messages via email as well as reports for medical professionals, clients, or patients.
Receive information concerning bad events and take all steps to deal with it in time in order to ensure that the information about cases is properly reflected in tracking and safety databases.
Check the updates regarding cases to ensure that all processes are performed properly and cases have been dealt with accordingly.
Ensure quality assurance review of safety documentation and communication prior to submission. Make sure there is adherence to the customer's procedure and internal SOPs.
Provide administrative support to drug safety and medical information through documentation and reporting.
Make sure there is proper maintenance of the confidentiality of any sensitive information of the clients and patients according to data protection policy.
Help the administration with general office work such as communication and record keeping.
Make sure that all tasks are carried out timely and to a high standard.
Qualification and Skill Requirement
Education: Bachelor’s degree in:
Life Sciences
Pharmacy or
Related discipline
Experience: Up to 2 years’ experience in Pharmacovigilance/Drug Safety
Detail-oriented with proper administration of safety data and documentation.
Good written and oral communication skills for corresponding and communicating with other parties.
Knowledge of the concept of pharmacovigilance and adverse event handling would be an added advantage. Able to organise and manage a workload of varying activities efficiently.
Well-organised and documentation skills are essential.
Good working knowledge of MS Office package (Word, Excel, Outlook) will be an advantage.
Able to work in an individual capacity and also as a team in a busy environment
Salary and Benefits
ProPharma Group provides a salary structure comparable to industry benchmarks. For the role of Drug Safety Assistant, the remuneration levels are between INR 4.5-7 LPA given the experience and qualifications of respective candidates.
As far as the employees’ benefits are concerned, this is an opportunity for them to gain some insights into the multidisciplinary nature of pharmacovigilance and drug safety operations.
In addition, employees can receive various benefits that include health and fitness initiatives, paid leaves, and help with career progression.
Role Importance and Career Growth
The Drug Safety Assistant is vital in tracking and following up on adverse events accurately, thus improving both regulatory compliance and patient safety. In addition, this job improves the entire pharmacovigilance operation in terms of its effectiveness and efficiency.
Those fundamental skills acquired can later serve as a basis for anyone who wants to continue a career in pharmacovigilance, e.g., employees can apply for positions like Drug Safety Associate, Pharmacovigilance Associate, or Case Processing Specialist.
How To Apply
If this is the position you seek to apply for, you should apply through the following procedure:
Create your account in Jobslly.
Search for the position Drug Safety Assistant/ ProPharma.
Upload your updated resume.
Upload all the related certificates.
Complete the application form.
Ensure your resume highlights relevant education, attention to detail, and any experience in pharmacovigilance or administrative support.
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.