Are you passionate about ensuring patient safety in clinical trials? GlaxoSmithKline (GSK), a global leader in biopharma, is hiring an Assistant Manager – Pharmacovigilance in Worli, Mumbai. This full-time role offers an exciting opportunity to support pharmacovigilance (PV) operations, ensuring compliance with local and global regulations while contributing to GSK’s mission of uniting science, technology, and talent to get ahead of disease together. If you have experience in pharmacovigilance and a strong understanding of clinical trial safety reporting, this role is your chance to thrive in a dynamic, purpose-driven environment.
Key Responsibilities
As an Assistant Manager – Pharmacovigilance, you will play a critical role in supporting the Lead Named Safety Contact (NSC) in managing Human Safety Information (HSI) and Adverse Events (AEs) for clinical trials. Your responsibilities include:
- Daily Safety Monitoring: Review PV and IN Safety mailboxes daily to action HSI/AEs and ensure timely regulatory reporting.
- Case Management: Redact cases lacking consent for Personally Identifiable Information (PII) or Sensitive Personal Data (SPD) and forward to the Global Service Provider.
- Regulatory Submissions: Submit Serious Adverse Events (SAEs) via the SUGAM system, forward submission proof to update safety databases, and perform due analysis for Ethics Committees.
- Report Preparation: Prepare India-specific Periodic Safety Update Reports (PSURs) for Pharma and Vaccines products and submit to the Health Authority (HA).
- Compliance and Audits: Coordinate for inspections, audits, and CAPAs, ensuring compliance with GSK’s global PV standards and local regulations.
- Program Support: Notify the MSV team of new Market Research, Patient Support Programs, or product launches, and support local Risk Management Plans (RMPs).
- Training and Collaboration: Conduct HSI/AE training, review clinical study protocols, and collaborate with global teams on PV activities.
Qualifications and Skills
To succeed in this role, candidates should meet the following requirements:
Basic Qualifications
- Bachelor’s degree in Science, Pharmacy, Life Sciences, or a related field.
- Minimum 3 years of experience in pharmacovigilance operations.
- Strong knowledge of pharmacovigilance regulations and methodologies.
- Proficiency in safety databases and IT systems, including Microsoft Excel.
- Excellent attention to detail, organizational, and communication skills.
- Strong time management and prioritization abilities.
Preferred Qualifications
- Master’s degree in Health Sciences or a related field.
- Experience in clinical trial safety reporting from a Sponsor perspective.
- Familiarity with aggregate reports (e.g., PSURs) and Risk Management Plans.
- Ability to work in a matrixed environment and handle audits/inspections.
- Industry experience in pharmacovigilance is highly desirable.
Benefits of Working at GSK
Joining GSK means being part of a global biopharma company dedicated to improving the health of billions. Benefits include:
- Purpose-Driven Culture: Work in an environment that values innovation, inclusion, and impact.
- Career Growth: Access opportunities to grow and thrive in a dynamic, global organization.
- Supportive Workplace: Enjoy a collaborative, inclusive setting where your contributions are valued.
- Health and Wellbeing: Benefit from GSK’s focus on employee wellness and development.
How to Apply
