Join CoreLEX Solutions Pvt Ltd, a trusted regulatory affairs and compliance company based in Okhla Industrial Area, New Delhi, founded to provide comprehensive services across pharmaceuticals, biotech, medical devices, and nutraceuticals. Specializing in regulatory strategy, pharmacovigilance, and compliance with CDSCO and FSSAI, CoreLEX supports national and international clients with USFDA-compliant processes.
Rated 4.0/5 for expertise on industry forums, CoreLEX is hiring Pharmacovigilance Senior Associates with 1-2 years of experience for its New Delhi office, focusing on aggregate safety reports, ICSRs, and quality assurance in pharmacovigilance services.
Recruitment Details: Pharmacovigilance Senior Associate
This hiring seeks Pharmacovigilance Senior Associates to manage safety reporting and compliance at CoreLEX’s Okhla Phase II office, leveraging safety databases like ARGUS and MedDRA for drug safety monitoring.
Job Location
CoreLEX Solutions Pvt Ltd
B-1/1, Okhla Industrial Area, Phase II, New Delhi, Delhi – 110020
Landmark: Near Okhla Metro Station
Department
Pharmacovigilance
Designation
Senior Associate
Qualification
- B.Pharm / M.Pharm / Pharm.D / BDS / BUMS / M.Sc. (Life Sciences: Biotechnology, Microbiology, Biochemistry)
Experience
- 1-2 years in pharmacovigilance, preferably with safety database experience
Number of Openings
- Multiple (likely 2-4 based on project scale)
Key Responsibilities
- Safety Reporting:
- Ensure timely submission of aggregate safety reports (PSURs, PADERs) and Individual Case Safety Reports (ICSRs)
- Perform quality reviews, verifying expectedness, causality, and seriousness of adverse events
- Prepare and evaluate PSURs and line listings per regulatory timelines
- Case Management:
- Investigate and resolve queries, initiating follow-up requests for ICSRs
- Identify adverse events (AEs) from peer-reviewed scientific literature
- Compose or review medically pertinent safety narratives
- Data Management:
- Conduct periodic reconciliations and maintain trackers
- Perform data entry into safety databases (ARGUS, ARISg, Clinevo) using MedDRA
- Quality Assurance:
- Execute QA activities (deviations, CAPA processes)
- Lead root cause investigations and prepare for internal/external PV audits
- Compliance:
- Understand and apply Pharmacovigilance Master File (PSMF), Safety Management Plans (SMP), Safety Data Exchange Agreements (SDEAs), and Pharmacovigilance Agreements
- Ensure compliance with cGMP and 21CFR Part 11
Key Skills
- Technical Expertise:
- Proficiency in safety databases (ARGUS, ARISg, Clinevo)
- Strong knowledge of MedDRA coding and ICH guidelines
- Experience with PSURs, ICSRs, and line listings
- Familiarity with CAPA, PV audits, and regulatory compliance
- Analytical Skills:
- Ability to assess causality, seriousness, and expectedness
- Expertise in literature review and narrative writing
- Soft Skills:
- Strong attention to detail and time management
- Excellent communication for query resolution and audit preparation
- Ability to work in a fast-paced, regulatory-driven environment
Salary
- ₹4.5–6.5 Lakhs/year (estimated based on ₹5.2 Lakhs average for PV Senior Associates with 1-3 years experience in New Delhi)
Why Join CoreLEX Solutions?
CoreLEX, a boutique CRO, is praised for its regulatory expertise and client-centric approach, with a 4.0/5 rating on industry forums for compliance services. The Okhla Phase II office supports global pharmacovigilance, handling ICSRs and aggregate reports for pharma and biotech clients.
Employees value the learning environment (4.2/5) but note challenges like limited facilities (no subsidized canteen) and shift work. With a growing presence in New Delhi’s regulatory hub and partnerships with CDSCO-compliant firms, CoreLEX offers a dynamic platform for PV professionals.
Key Benefits
- Gain expertise in ARGUS, MedDRA, and USFDA-compliant PV processes
- Contribute to global drug safety for pharma and biotech clients
- Work in New Delhi’s Okhla, a key industrial hub
- Access mentorship from experienced regulatory professionals
- Build a career in a niche, high-demand PV sector
How to Apply
Send your CV or portfolio to varun@corelex.in with subject “Pharmacovigilance Senior Associate – New Delhi” by May 20, 2025. Alternatively, apply via www.corelexsolutions.com. Include:
- Updated CV with passport-size photo
- Educational certificates (B.Pharm, M.Pharm, Pharm.D, BDS, BUMS, M.Sc.)
- Experience certificates and last 3 months’ payslips
- Aadhar and PAN card copies
- Total Experience, Current CTC, Expected CTC, Notice Period
- Preparation:
- Review MedDRA, ICH E2B(R3), and PSUR guidelines
- Practice ICSR processing and narrative writing
- Prepare for CAPA, audit, and safety database questions
- Study SMP, SDEA, and PSMF frameworks
- Note: CoreLEX does not charge recruitment fees; verify communications via @corelex.in emails. For queries, contact Varun at varun@corelex.in or visit www.corelexsolutions.com.
About CoreLEX Solutions
CoreLEX Solutions Pvt Ltd, based in Okhla Phase II, New Delhi, specializes in regulatory affairs and pharmacovigilance, acting as a bridge between organizations and regulators like CDSCO and FSSAI. With a team of experienced professionals, CoreLEX supports product development, registration, and commercialization, ensuring compliance with global standards.
The company’s focus on PV includes ICSR management, aggregate reporting, and audit readiness for pharmaceuticals and medical devices.
Our Mission
- Ensure drug safety through robust pharmacovigilance
- Provide client-centric regulatory solutions
- Foster a collaborative, compliance-driven workplace
Apply now at varun@corelex.in or www.corelexsolutions.com. Join CoreLEX Solutions in New Delhi and advance global drug safety
