Cencora – Senior Specialist, Pharmacovigilance Epidemiology & Risk Management
Company: Cencora (Affiliated: PharmaLex India Private Limited)
Location: India
Job Type: Full-Time
Work Mode: Not explicitly stated (likely Hybrid/On-site depending on project)
Experience: 4+ Years (Pharmacovigilance / Drug Safety)
Qualification: Life Sciences Degree
Compensation: Not disclosed in the job description
Pharmacovigilance and drug safety consulting roles are among the highest-demand jobs in the pharmaceutical industry, especially positions focused on signal detection, risk management, and regulatory safety reporting.
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Job Summary
Cencora is hiring a Senior Specialist – Pharmacovigilance Epidemiology & Risk Management to support global drug safety operations, regulatory submissions, and risk management strategies. This role focuses on signal detection, aggregate safety reporting, pharmacovigilance consulting, and benefit-risk evaluation across the product lifecycle.
You will work on high-impact deliverables such as PSURs, DSURs, RMPs, signal assessment reports, and regulatory responses, making this a strong career opportunity in pharmacovigilance, regulatory affairs, and drug safety consulting.
This role is ideal for professionals aiming to grow in:
Pharmacovigilance (PV)
Drug Safety & Risk Management
Regulatory Affairs & Safety Writing
Pharmacoepidemiology
Key Responsibilities
Signal Detection & Safety Surveillance
Perform literature search and database screening for safety signals
Conduct signal detection and signal analysis using global safety data
Prepare:
Signal Detection Reports
Signal Assessment Reports (SARs)
Utilize tools like EVDAS for signal identification
Aggregate Safety Reporting
Author and review key regulatory documents:
Periodic Safety Update Reports (PSUR / PBRER)
Development Safety Update Reports (DSUR)
Periodic Adverse Drug Experience Reports (PADER)
Addendum to Clinical Overview (ACO)
Clinical Expert Statements
Ensure compliance with global regulatory requirements
Risk Management & Pharmacovigilance Strategy
Develop and maintain Risk Management Plans (RMPs)
Identify safety concerns and recommend risk minimization strategies
Support lifecycle safety management of pharmaceutical products
Regulatory Communication & Compliance
Respond to regulatory authority queries (e.g., PRAC, referrals)
Communicate benefit-risk changes and safety updates
Ensure adherence to global pharmacovigilance regulations
Quality Review & Documentation
Review safety documents for completeness, accuracy, and consistency
Maintain documentation standards aligned with SOPs and guidelines
Support SOP writing, review, and training material development
Client & Project Management
Manage client relationships and ensure service delivery excellence
Develop customized pharmacovigilance solutions for clients
Lead or contribute to project management activities
Represent the company in interactions with clients and authorities
Required Skills & Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field
Minimum 4+ years of pharmacovigilance experience
Strong expertise in:
Signal Detection & Signal Management
Aggregate Reporting (PSUR, DSUR, PADER)
Risk Management Plans (RMPs)
Knowledge of:
ICH-GVP guidelines
Global pharmacovigilance regulations
Benefit-risk assessment methodologies
Experience with:
EVDAS or similar signal detection tools
Safety databases and reporting systems
Strong communication and scientific writing skills
Fluent in English (business level)
Preferred Skills (High-Impact SEO Keywords):
Pharmacoepidemiology
Regulatory Writing & Medical Writing
Clinical Safety & Risk Assessment
Safety Signal Evaluation
SOP Development & Compliance
Project Management in PV
Perks & Benefits
Work with a global healthcare consulting and services organization
Exposure to international pharmacovigilance projects and regulatory bodies
Opportunity to work on high-impact drug safety strategies
Career growth in pharmacovigilance consulting and leadership roles
Collaborative and client-focused work environment
About the Company
Cencora is a global healthcare solutions provider focused on improving patient outcomes through pharmaceutical services, consulting, and supply chain innovation. Through its affiliate PharmaLex, the company delivers specialized expertise in pharmacovigilance, regulatory affairs, and clinical development.
Why This Role is High-Value in Pharma Careers
The Senior Specialist – Pharmacovigilance Epidemiology & Risk Management role is at the core of modern drug safety and regulatory compliance. With increasing global regulations and focus on patient safety, professionals skilled in signal detection, aggregate reporting, and risk management are highly sought after.
This role provides direct exposure to:
Global regulatory authorities (EMA, PRAC, etc.)
Advanced pharmacovigilance systems
Benefit-risk evaluation frameworks
End-to-end drug safety lifecycle
Career growth opportunities include:
Pharmacovigilance Lead
Drug Safety Scientist
Risk Management Specialist
Regulatory Affairs Expert
Application Process
Apply through the official Cencora careers portal
Highlight experience with:
PSUR / DSUR / RMP
Signal Detection & EVDAS
ICH-GVP & Pharmacovigilance systems
Regulatory safety writing
Call to Action
If you want to advance your career in pharmacovigilance, drug safety, and global regulatory consulting, this is a high-impact opportunity.
Apply now and become a key player in ensuring patient safety and regulatory excellence with Cencora.
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