Fidelity Health Services – Pharmacovigilance Opportunity for Senior Drug Safety Physician

Join Fidelity Health Services (FHS), a leading pharmacovigilance (PV) organization, as a Senior Drug Safety Physician at our Delhi office. FHS, a trusted partner for global pharma companies, delivers end-to-end PV solutions with a focus on quality, compliance, and innovation.

Serving clients across North America, Europe, and Asia, we manage 50,000+ ICSRs annually and support 100+ clients in regulatory compliance. Rated 3.9/5 for work culture (AmbitionBox, 150+ reviews), salaries for senior PV roles range from ₹15–25 Lakhs/year (Glassdoor). Be part of our dynamic team driving safety excellence in pharmaceuticals!

Job Posting Details

• Role: Senior Drug Safety Physician
• Department: Pharmacovigilance
• Location: Fidelity Health Services Pvt. Ltd., 3rd Floor, Tower B, World Trade Tower, C-1, Sector 16, Noida, Delhi NCR 201301 (office-based)
• Job Code: FHS/2025/INS/14
• Application: Email resume to hrrecruitment@fidelityhs.com, subject: “FHS/2025/INS/14 – Senior Drug Safety Physician – Delhi.”
• Contact: +91-120-466-6000, hrrecruitment@fidelityhs.com
• Website: www.fidelityhs.com

Notes:

• Fraud Alert: FHS does not charge fees for recruitment. Verify via hrrecruitment@fidelityhs.com or www.fidelityhs.com.

Why Fidelity Health Services?

FHS, established in 2010, is a GVP-compliant PV leader, offering services like ICSR processing, signal detection, aggregate reporting, and risk management for generics, biologics, and medical devices. Our Delhi NCR office supports global clients with E2B(R3) submissions and MedDRA coding.

Rated 4.0/5 for skill development (AmbitionBox), we provide training in ARGUS, ARISg, and EMA EudraVigilance, but some note high workload (3.7/5 for management). Benefits include health insurance, performance bonuses, and team events. Join a team contributing to India’s $5 billion PV market (15% CAGR, Invest India), ensuring drug safety for global populations.

Job Position: Senior Drug Safety Physician – Pharmacovigilance

• Qualification: MBBS or Postgraduate (MD, DNB)
• Experience: 8–10 years in pharmacovigilance
• Vacancies: ~1–2 (estimated)
• Location: Delhi NCR (office-based)

Key Responsibilities:

1. Perform medical review of Individual Case Safety Reports (ICSRs), aggregate reports (PSURs, PADERs), signal detection outputs, and health hazard assessments.
2. Oversee and manage quality of safety deliverables from external vendors (e.g., ICSR processing, literature screening).
3. Act as the key medical contact across safety operations, ensuring clinical accuracy and compliance.
4. Support drafting and implementation of SOPs and system processes (e.g., ARGUS, EudraVigilance).
5. Contribute to strategic planning and medical oversight for PV projects, aligning with global regulations.
6. Collaborate with regulatory affairs, medical affairs, and quality teams to ensure timely deliverables.
7. Provide medical expertise during regulatory inspections (e.g., USFDA, EMA) and internal audits.
8. Mentor junior PV staff on GVP, MedDRA coding, and causality assessments.

Skills:

• Technical: Expertise in ICSR medical review, signal detection, aggregate reporting, and health hazard assessments.
• Regulatory: Strong knowledge of USFDA, EMA, GVP, ICH E2B(R3), and global PV regulations.
• Leadership: Proven ability to manage vendors, lead projects, and oversee quality deliverables.
• Interpersonal: Excellent communication, training, and collaboration skills; ability to engage cross-functional teams.

• Why Join?: Lead PV operations in a forward-thinking organization, ensuring drug safety for global markets.

Who Can Apply?

• Qualifications: MBBS or Postgraduate (MD, DNB).
• Experience: 8–10 years in pharmacovigilance, with end-to-end PV deliverables (ICSRs, PSURs, signal detection).
• Key Skills:
  • PV Expertise: Medical review, signal detection, aggregate reporting, health hazard assessments.
  • Regulatory Knowledge: USFDA, EMA, GVP, ICH guidelines, E2B(R3) submissions.
  • Leadership: Vendor management, SOP development, audit readiness.
  • Soft Skills: Strategic thinking, communication, quick onboarding readiness.
• Preferred:
  • Experience with ARGUS, ARISg, or EudraVigilance systems.
  • Prior PV roles in generics, biologics, or medical devices.
  • USFDA/EMA inspection exposure; immediate joiners; local candidates (Delhi NCR).

How to Apply

1. Submit Resume: Email to hrrecruitment@fidelityhs.com, subject: “FHS/2025/INS/14 – Senior Drug Safety Physician – Delhi.” Highlight PV experience and regulatory knowledge.
2. Prepare Documents: If shortlisted, bring CV, MBBS/Postgraduate certificates, experience letters, last 3 months’ payslips, Aadhaar/PAN copies, 2 photos.
3. Study Up:
   • Review GVP, ICH E2B(R3), MedDRA coding, and signal detection processes.
   • Study FHS services (ICSR processing, aggregate reporting). Visit www.fidelityhs.com.
   • Prepare examples (e.g., “How did you handle a complex ICSR causality assessment?” or “How did you improve vendor quality in PV?”).
   • Understand USFDA/EMA PV requirements and health hazard assessments.
   • Address workload concerns diplomatically (31% rate work-life balance low, AmbitionBox).
4. Interview: Expect technical (70%) and leadership-focused (30%) questions. Emphasize PV expertise, regulatory compliance, and vendor management. Sample questions:
   • “How do you approach medical review of an ICSR with missing data?”
   • “Describe a time you improved a PV process through an SOP.”
   • “How do you ensure vendor deliverables meet GVP standards?”
   • Process takes ~1–2 weeks; 30% rate interviews as challenging (Glassdoor).

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Why Delhi NCR?

FHS’s Delhi NCR office, located in Noida’s World Trade Tower, is part of India’s $5 billion PV market (15% CAGR, Invest India). Delhi NCR offers 500+ PV jobs (Naukri) and a vibrant lifestyle (₹15,000/month for 1BHK, AmbitionBox). Accessible via metro (Sector 16 station) and Noida Expressway, it’s ideal for PV careers in a global hub.

Contact Information

• Email: hrrecruitment@fidelityhs.com
• Phone: +91-120-466-6000
• Location: 3rd Floor, Tower B, World Trade Tower, C-1, Sector 16, Noida, Delhi NCR 201301
• Connect: LinkedIn
• Website: www.fidelityhs.com

Apply Now to join Fidelity Health Services as a Senior Drug Safety Physician in Delhi and lead pharmacovigilance excellence for global markets!