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Senior Pharmacovigilance Scientist

3-6 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Full Time Education: M.Pharm/MBBS\BDS/Life Science 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

Job Title:

Senior Pharmacovigilance Scientist


Location:

Hyderabad, India


Company:

Sanofi


Role Overview:

The Senior Pharmacovigilance Scientist (PV Science Expert) plays a global role within a diverse and international safety surveillance team. This position supports the full lifecycle of various products by identifying, evaluating, and analyzing safety data for both marketed products and those in clinical development.


Key Responsibilities:

  • Manage ongoing core signal detection activities for GSLs/GSMs, synthesizing data from multiple sources (PV database, literature, external databases, etc.)

  • Coordinate and author draft Health Hazard Evaluations (HHEs) and Safety Evaluation Reports (SERs)

  • Manage data entry and tracking of signals, ME, and INR in SMART tool; support SMART-related activities

  • Review periodic signal detection reports (NINR, UDR, SD for PBRERs)

  • Contribute to responses for Health Authority queries and stakeholder inquiries; support strategy and data review

  • Serve as a core member of the Safety Management Committee (SMC); prepare data outputs and presentations

  • Support safety content development for regulatory filings and new drug applications

  • Assist in drafting EU Risk Management Plans (RMPs)

  • Contribute to risk and benefit-risk assessments for marketed products

  • Collaborate with internal and external stakeholders across functions (Medical Safety, PV Quality, Regulatory, etc.)

  • Provide support for OTC SWITCH SER

  • Participate in audit and inspection preparation


Experience Required:

  • 3–6 years of industry experience in drug safety and risk management

  • Basic understanding of drug development and regulatory guidelines

  • Experience in medical coding and interpreting scientific data


Soft Skills:

  • Strong stakeholder management, negotiation, and communication skills

  • Effective in a cross-functional, multicultural, and global environment

  • Excellent organization and project management abilities

  • Strategic thinking and leadership capability


Technical Skills:

  • Proficient in evaluating and synthesizing scientific data

  • Knowledge of US/EU pharmacovigilance regulatory requirements

  • Expertise in signal detection and risk management

  • Familiarity with international regulations and good practices in PV

  • High attention to detail; strong writing and analytical skills

  • Ability to work independently and as part of a team

  • Excellent collaboration and influencing skills


Education:

  • Preferred degrees:

    • Master’s in Pharmacy (M.Pharm)

    • Master of Health Science

    • Physician Assistant

    • MBBS

    • BDS


Languages:

  • Fluent in English (written and verbal)


Why Join Sanofi?

At Sanofi, progress is driven by people who are open to new ideas, embrace change, and are committed to discovering the extraordinary. We champion diversity, inclusion, and equal opportunity for all.