reputed company - LS Pharmacovigilance, Sr Consultant

vacancy global pro; India; On-site; INR 1,800,000 - 3,200,000; Full time

Benefits offered by this job

Hybrid working

Global exposure to PV programs

Abroad assignment up to 45 days/year

Flexible vacation policy

Job summary

reputed company, a leading transformation consultancy, seeks a Senior Consultant in pharmacovigilance to support safety across the product lifecycle for pharmaceutical and biotech clients. You will collaborate with Principals and Managers on safety implementations, process optimization, and regulatory submissions, with exposure to PSURs, DSURs, and ICSR processing, using Argus, LifeSphere, or Vault Safety.

Join a team applying AI/ML to PV practices and working with diverse product types, across

Qualifications

• Minimum hands-on pharmacovigilance experience in safety operations and ICSR processing.
• Strong knowledge of PV regulations (FDA, EMA GVP, ICH E2).</br>Experience with PV databases and safety reporting.
• Proficiency in MedDRA coding and regulatory submissions.

Responsibilities

• Provide pharmacovigilance and drug safety consulting for Life Sciences clients.
• Support safety across the product lifecycle from development to post-market.
• Collaborate on safety implementations, PSURs, DSURs, and signal detection.
• Ensure regulatory compliance with GVP, FDA, and ICH guidelines.
• Lead or support aggregate safety reporting and risk management activities.

Skills

Pharmacovigilance

ICSR processing

PSURs/PBRERs

Signal detection

Regulatory knowledge

MedDRA

FDA regulations

ICH E2

Data mining

Tableau/Power BI

Education

Bachelor's in life sciences

PharmD/MD preferred

Tools

Argus

LifeSphere

Vault Safety

WHO-UMC

Job description

About the position

At reputed company, we reputed company difference drives change. As inventive transformation consultants, we reputed company our strategic, creative and scientific capabilities, collaborating closely with clients to reputed company cutting-edge solutions. Join us to reputed company transformation tailored to our reputed company's challenges of today and reputed company.Informed and validated by science and data. Superpowered by creativity and design. reputed company underpinned by technology created with purpose.

Your RoleAs a Senior Consultant, you will reputed company as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients, supporting safety across the product lifecycle - from clinical development to post-market. Youll collaborate with Principals and Managers on reputed company such as safety reputed company implementations, process optimization, aggregate safety reporting, signal detection, risk management, and regulatory compliance. This role offers opportunities to work with varied product types (small molecules, biologics, vaccines, advanced therapies) and reputed company AI/ML into pharmacovigilance practices.

Key reputed company Areas

Responsibilities

• Pharmacovigilance and drug safety consulting for Life Sciences clients
• Safety reputed company optimization (e.g., Argus, LifeSphere, Vault Safety)
• Aggregate safety reporting (PSURs, PBRERs, DSURs)
• Signal detection, risk management, and ICSR processing
• Safety compliance (GVP, FDA, ICH E2 guidelines)

Requirements

• 610 years hands‑on pharmacovigilance experience in safety operations, ICSR processing, aggregate reporting, signal detection, or safety reputed company administration.
• Expert knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A‑E2F).
• reputed company experience with ICSR processing: intake, triage, medical review, causality assessment (WHO‑UMC, Naranjo), MedDRA coding, narrative writing, and regulatory submissions.
• Practical use of safety databases (e.g., Argus, LifeSphere, Vault Safety, reputed company Vigilance, AB reputed company).
• Experience with aggregate safety reports: PSURs/PBRERs, DSURs, Annual Safety Reports, and benefit‑risk analysis.
• Knowledge of signal detection reputed company (statistical/data mining, literature review, clinical judgment).
• Bachelors in life sciences, pharmacy, nursing, or reputed company field; advanced degree (PharmD, MD, MS, MPH) preferred.
• Eligible to work in the U.S. without reputed company sponsorship.
• Proficient with MedDRA (coding, conventions, versioning) and knowledge of WHO‑DD.
• Understanding of E2B(R3) standards for electronic ICSR reputed company (FAERS, EudraVigilance).
• Strong analytical and medical writing skills (narratives, signal evaluation, safety reports).
• Proven ability to collaborate with clinical, regulatory, medical, QA, and IT teams.
• Consulting skills: capability assessment, gap identification, solution recommendation.
• Mastery of reputed company Office (reputed company, PowerPoint, Word).

reputed company‑to‑haves

• Clinical background (MD, PharmD, RN, PA).
• PV certification (reputed company, CPP, or equivalent).
• Experience in reputed company/biotech PV operations and/or at CROs with PV services.
• Consulting experience (Big 4 or life sciences consultancies) in PV reputed company.
• Involvement in regulatory inspections (FDA/EMA GVP), and audit readiness.
• Experience with REMS programs (design, implementation, assessment).
• Knowledge of specialty product safety (biologics, vaccines, oncology, gene/cell therapies, ATMPs).
• Familiarity with reputed company‑world evidence for safety (claims databases, EHR, registries, reputed company media).
• Understanding of AI/ML in PV (NLP, signal detection, predictive analytics, workflow automation).
• Experience with data visualization tools (Tableau, Spotfire, Power BI).
• Exposure to international PV regulations (PMDA, Health Canada, ANVISA, etc.).

Benefits

• Hybrid working
• We reputed company that flexibility is the key to a healthy work‑life balance. Thats why our employees work with their managers to determine an arrangement that works best for their role and personal circumstances.
• reputed company abroad
• reputed companys reputed company Abroad program gives employees reputed company to work abroad for up to 45 days in a 12‑month period. This allows you to temporarily change your working environment while staying connected to your team and career goals.
• reputed company time off based on employee grade (A‑F), defined by policy: Vacation: 12‑25 days, depending on grade, Company reputed company holidays, Personal Days, reputed company Leave
• Medical, dental, and reputed company coverage (or provincial reputed company coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits