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Assistant Manager, Pharmacovigilance, Epidemiology & Risk Management

0-2 years
Not Disclosed
10 Sept. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Assistant Manager – Pharmacovigilance, Epidemiology & Risk Management

Location: Noida, India
Category: Consulting
Job Type: Full-Time
Job ID: R2516356
Posted Date: August 29, 2025
Company: Cencora (Affiliated Company: PharmaLex India Private Limited)


About Cencora

At Cencora, our team members are at the heart of everything we do. We are united in our purpose to create healthier futures, improving the lives of people and animals worldwide. If you want to make a meaningful difference at the center of health, join our innovative team today.


Key Responsibilities

  • Conduct literature database searches and screen hits for new safety data on medicinal products, reportable and non-reportable cases, and signal detection.

  • Author key regulatory documents including:

    • Periodic Safety Update Reports (PSURs / PBRER format)

    • Development Safety Update Reports (DSURs)

    • Addendum to the Clinical Overview (ACO)

    • Periodic Adverse Drug Experience Reports (PADERs)

    • Clinical Expert Statements

  • Handle publishing, distribution, archiving, and submission of safety reports.

  • Prepare signal detection reports (including EVDAS screening, if applicable) and Signal Assessment Reports (SARs).

  • Write and maintain Risk Management Plans (RMPs), identifying safety concerns and recommending risk minimization activities across the product life cycle.

  • Review regulatory documents for completeness, consistency, and overall quality.

  • Mentor and train new staff while ensuring compliance with training requirements.

  • Draft responses to PRAC assessment reports and other Health Authority requests (e.g., referrals).

  • Collaborate with internal and external stakeholders to ensure compliance with regulatory requirements.

  • Prepare responses to Health Authority (HA) questionnaires using safety database, literature, clinical trial, and epidemiology data.

  • Formulate strategies for safety issues, HA requests, and integrated benefit–risk evaluations.

  • Support project management activities and act as client contact point, when required.


Qualifications & Skills

  • Strong expertise in pharmacovigilance, epidemiology, and risk management practices.

  • Hands-on experience with regulatory writing, signal detection, RMPs, and safety evaluations.

  • Knowledge of health authority requirements, compliance, and benefit–risk strategy.

  • Ability to mentor teams, ensure documentation quality, and manage client interactions.

  • Strong communication, problem-solving, and analytical skills.


What Cencora Offers

  • Comprehensive benefits aligned to local market practices (eligibility and start dates may vary).

  • Inclusive, collaborative work culture with career development opportunities.

  • Commitment to equal employment opportunity regardless of race, color, religion, gender, identity, orientation, genetics, origin, age, disability, or veteran status.

  • Reasonable accommodations for individuals with disabilities during the employment process.