Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
Are you passionate about ensuring the safety of pharmaceuticals and contributing to regulatory compliance? DDReg Pharma Pvt. Ltd. is looking for talented individuals to join its Pharmacovigilance team in Gurgaon, offering a key role in Literature Screening and ICSR (Individual Case Safety Reports) management. This exciting opportunity is perfect for those looking to advance their career in drug safety and regulatory services. With a reputation for excellence, DDReg is the ideal place for professionals eager to make a meaningful impact in the pharmaceutical industry. Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
Why Work at DDReg Pharma?
DDReg Pharma Pvt. Ltd. is a globally recognized leader in regulatory and pharmacovigilance services, helping pharmaceutical companies meet global safety standards, navigate regulatory requirements, and minimize risks. We provide market access and compliance solutions that ensure the safety of medicinal products, making DDReg a trusted partner to healthcare companies worldwide. With a collaborative, Work/Life Balance-focused culture, we are dedicated to supporting the growth and development of our employees.
If you’re looking for an innovative work environment that encourages learning, growth, and collaboration with industry experts, then DDReg is the place for you! Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
Job Responsibilities
As part of the Pharmacovigilance team, the Literature Screening & ICSR role is critical in ensuring drug safety by monitoring scientific literature and managing safety reports. The job provides a diverse set of responsibilities that involve both technical and regulatory expertise. Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
Here’s what you’ll do in this role:
- Literature Screening: You’ll monitor scientific and medical literature sources regularly for reports of adverse events associated with pharmaceutical products. This is crucial for identifying potential risks early.
- ICSR Management: Extract relevant case information from literature reports and submit Individual Case Safety Reports (ICSRs) in compliance with regulatory protocols and timelines.
- Report Documentation: Maintain meticulous records of all case reports, ensuring all information is correctly documented and stored for future regulatory submissions.
- Regulatory Compliance: Adhere to global pharmacovigilance regulations (e.g., EMA, US FDA) and timelines, ensuring the reports meet all necessary guidelines. You will also collaborate with cross-functional teams to streamline processes.
- Regulatory Submissions: Assist in preparing and submitting reports to health authorities and relevant stakeholders to ensure compliance with safety requirements. Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
Educational Qualifications & Experience
To excel in this role, you must have the following qualifications and experience:
- Educational Background: A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Pharmacovigilance, or a related field.
- Experience:
- Candidates with 1-2 years of experience or those with 5-7 years in literature handling and ICSR management in a pharmacovigilance (PV) setup are ideal.
- Familiarity with literature screening tools and databases such as PubMed, Embase, or other similar platforms is required.
- Regulatory Knowledge: A good understanding of global pharmacovigilance regulations and processes, including those from the EMA and US FDA, is crucial.
Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
Key Skills for Success
To be successful in this role, you need to demonstrate the following:
- Literature Monitoring Expertise: Proven experience using scientific tools and databases to monitor literature for adverse event detection.
- ICSR Expertise: Strong knowledge and experience with ICSR submission processes and pharmacovigilance databases.
- Communication Skills: Excellent verbal and written communication skills, essential for collaborating with cross-functional teams and preparing reports for stakeholders.
- Time Management: The ability to meet strict regulatory timelines while managing multiple tasks effectively.
Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
Immediate Availability Required
We are only considering candidates who are immediately available for joining. If you are ready to take on a new challenge without delay, we want to hear from you. Literature Screening & ICSR Role in Pharmacovigilance at DDReg Pharma
How to Apply
If you have the qualifications and experience required for this role, and are available to start immediately, please send your updated CV to Sugandha.Mishra@ddreg.in with the subject line:
“Application for Literature Screening & ICSR Role | Immediate Joiner”.
Join Us at DDReg Pharma
Be a part of a team that is making a difference in the pharmaceutical industry. As part of the Pharmacovigilance team, you’ll be working in a fast-paced, dynamic environment that offers excellent career growth opportunities. Apply now and help ensure the safety of pharmaceutical products worldwide!
Location: Gurgaon, India
Salary: Not Disclosed