PV Specialist – ICSR (B.Pharm/M.Pharm) | Hyderabad
Bring your 10–12 years of pharmacovigilance experience to a high-impact leadership role that advances patient safety in biologics clinical trials. Dr. Reddy’s Laboratories is recruiting a seasoned PV Specialist – ICSR (Clinical Trials) in Hyderabad to strengthen case processing quality, compliance, and oversight across global studies. If you are a B.Pharm/M.Pharm professional with deep ICSR expertise and hands-on biologics exposure, this is a career-defining opportunity to lead safety excellence at scale.
Company Overview
Dr. Reddy’s Laboratories is a globally respected pharmaceutical company known for science-led innovation and robust quality systems across generics, branded formulations, and biologics. The organization is committed to patient safety, regulatory compliance, and continuous improvement, operating with well-established pharmacovigilance frameworks aligned to ICH, GVP, and local health authority expectations. By joining Dr. Reddy’s, you’ll collaborate with cross‑functional teams in clinical development, medical affairs, regulatory affairs, quality, and biostatistics to ensure that the safety profile of investigational biologics is assessed accurately and communicated responsibly.
Job Role & Responsibilities
As a PV Specialist – ICSR (Clinical Trials), you will serve as a senior functional expert and quality guardian for individual case safety report processes. Key responsibilities include:
- ICSR Case Strategy & Oversight
- Own end‑to‑end ICSR case intake, triage, processing, medical assessment, and submission for clinical trials in biologics.
- Ensure timelines and quality standards are met for SAE/AE processing per ICH E2A/E2D/E2F and GVP modules.
- Drive Right‑First‑Time processing and foster a culture of data completeness and narrative quality.
- Quality, Compliance & Audit Readiness
- Lead CAPA activities following internal audits/inspections; proactively mitigate compliance risks.
- Maintain robust SOPs/WIs, contribute to process mapping, and implement continuous improvement initiatives.
- Partner with QA to ensure inspection readiness across the PV system.
- Medical & Scientific Excellence
- Guide MedDRA coding, medical review, and clinical relevance assessments for complex biologic products.
- Coordinate with study physicians for case narratives, causality assessments, and expectedness (IB/RSI) checks.
- Support signal detection inputs and provide case‑based insights to aggregate reports (DSUR, PBRER/PSUR, RMP updates).
- Safety Database & Technology
- Provide SME support on safety databases (e.g., Argus/ArisG) including configuration, validation rules, and E2B(R3) compliance.
- Ensure secure data handling in line with privacy/GCP requirements and study blinding controls.
- Cross‑Functional & Vendor Management
- Liaise with CROs and vendors for outsourced case processing, reconciliation, and TMF documentation.
- Lead or mentor case processing teams; deliver training refreshers and coaching for performance uplift.
- Metrics & Governance
- Track and report KQIs/KPIs (timeliness, quality, deviation rates).
- Present safety operations status to governance boards and clinical leadership.
Impact: Your stewardship will directly strengthen patient safety decisions, accelerate compliant submissions, and enhance the scientific integrity of biologics development.
Eligibility / Qualifications
- Education (mandatory): B.Pharm or M.Pharm.
- Experience: 10–12 years of end‑to‑end ICSR processing and oversight in clinical trials, with significant exposure to biologics.
- Technical Depth:
- ICSR lifecycle mastery (intake to submission), SAE processing, MedDRA coding, narrative writing, medical review support.
- Familiarity with Argus/ArisG or equivalent safety systems; working knowledge of E2B(R3).
- Strong command of ICH, GVP, and GCP; understanding of IB/RSI management, DSUR, PSUR/PBRER, RMP inputs.
- Vendor/CRO oversight, reconciliation with clinical data systems (EDC/eCRF), and TMF documentation.
- Behavioral Skills: Detail orientation, analytical thinking, stakeholder management, clear scientific communication, and audit/inspection confidence.
Location & Salary (if given)
- Location: Hyderabad, India.
- Work Model: On‑site/Hybrid as per business need (to be discussed with HR).
- Compensation: Competitive and commensurate with experience; final package will align with company policy and candidate credentials.
- Other Details: Senior individual‑contributor/lead responsibilities with potential mentoring scope.
Note: Salary specifics are determined by Dr. Reddy’s HR based on experience, skills, and internal benchmarks.
Application Process (Email)
Submit your resume to shaiksalmasultana@drreddys.com with the subject line:
Application – PV Specialist (ICSR, Clinical Trials) – Hyderabad – [Your Name]
Include the following details in the email body:
- Total PV experience (overall and specific years in ICSR clinical trials & biologics).
- Current organization and notice period.
- Key systems handled (Argus/ArisG) and MedDRA version familiarity.
- Highest qualification (B.Pharm/M.Pharm) and certifications/trainings.
- Current CTC and expected CTC.
- Preferred joining timeline and work model (on‑site/hybrid).
👉 For priority consideration, apply by 5 September 2025.
Frequently Asked Questions (FAQs)
1) Is biologics experience mandatory?
Strong biologics exposure in clinical trial PV is highly preferred and will be a key differentiator for this role.
2) Which safety databases are used?
Experience with Oracle Argus or ArisG is valued. Exact platforms will be discussed during interviews.
3) Will I work on aggregate reports too?
Primary focus is ICSR clinical trials; however, you may contribute case‑derived insights to DSUR, PBRER/PSUR, and RMP sections as needed.
4) What’s the interview process like?
Typically involves technical PV discussions (ICSR scenarios, narratives, MedDRA coding cases), compliance/JPV questions, and stakeholder fit rounds.
5) Is relocation support provided?
Discuss with HR. Work model and any relocation considerations are handled as per company policy.
6) What is the salary range?
Compensation is market‑competitive and based on your experience in ICSR clinical trials, biologics, and leadership/oversight responsibilities.
7) What documents should I keep handy?
Updated CV, proof of qualification (B.Pharm/M.Pharm), experience letters, certifications/trainings, and notice period details.
Call to Action
Ready to lead ICSR excellence in biologics clinical trials at a top pharmaceutical organization?
➡️ Email your resume now: shaiksalmasultana@drreddys.com
➡️ Subject: Application – PV Specialist (ICSR, Clinical Trials) – Hyderabad – Your Name
➡️ Tip: Highlight complex cases handled, audit exposure, and any E2B(R3) implementation projects on your CV.
Summary Table
| Category | Details |
|---|---|
| Company | Dr. Reddy’s Laboratories |
| Vacancies | PV Specialist – ICSR (Clinical Trials), Hyderabad – Vacancy: Open |
| Required Education | B.Pharm/M.Pharm |
| Experience | 10–12 years in ICSR processing/oversight within clinical trials; biologics exposure preferred |
To apply for this job email your details to shaiksalmasultana@drreddys.com