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Specialist Drug Safety

3+ years
₹13–18 LPA
10 July 26, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Specialist – Drug Safety | ADVANZ PHARMA
Location: Mumbai, Maharashtra (Hybrid)
Work Type: Full-time
Estimated Salary: ₹13–18 LPA (based on industry norms and role seniority)


About the Role:
ADVANZ PHARMA is looking for a highly skilled Specialist – Drug Safety to join their global medical office. The role focuses on leveraging scientific and drug safety expertise across medical affairs, pharmacovigilance, post-marketing research, and compliance. You'll be involved in authoring safety documents, managing regulatory compliance, and representing the company in scientific and inspection forums.


Key Responsibilities:

  • Draft and review PSURs and PADERs from a medical perspective.

  • Prepare Signal Detection Reports (DSR, DEP, SAR) and ensure quality and compliance.

  • Support medical writing activities related to safety reviews and evaluations.

  • Contribute to reports such as RMPs, CES, and HA responses within regulatory timelines.

  • Oversee safety-related variations and product information maintenance.

  • Stay updated on evolving PV regulations across Europe and ROW.

  • Represent ADVANZ PHARMA in scientific meetings, audits, and inspections.

  • Ensure documentation is properly structured and compliant with GPvP standards.

  • Collaborate with regulators, healthcare professionals, and internal teams.

  • Foster a culture of entrepreneurship, speed, and integrity in alignment with company values.


Qualifications:

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, or related discipline.

  • Postgraduate specialization in Pharmacovigilance, Clinical Research, or Regulatory Affairs is a plus.


Required Skills & Experience:

  • Strong background in Drug Safety/Pharmacovigilance in a pharmaceutical setting.

  • Proven track record in medical writing: PSURs, RMPs, safety sections of dossiers.

  • Knowledge of compliance tracking systems, safety databases, and PSMF.

  • Experience with PV audits and global regulatory inspections.

  • Ability to work across global teams and time zones.

  • Analytical mindset with excellent scientific data interpretation skills.

  • Excellent verbal and written communication.

  • Comfortable in a dynamic, entrepreneurial environment and quick decision-making scenarios.


Why Join ADVANZ PHARMA?

  • Opportunity to work in a global-facing drug safety team with room for leadership and innovation.

  • Culture of speed, transparency, and teamwork across all business functions.

  • Work on impactful global safety initiatives that affect patient care outcomes.

  • Be part of a growing company recognized for its integrity and collaborative work culture.