GSS Pharma Hiring Assistant Manager Pharmacovigilance
- Company Overview
- Job Role & Responsibilities
- Assistant Manager – Pharmacovigilance
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why This Role Matters — EEAT Alignment
- FAQs
Pharm D/M.Pharm PV Assistant Manager – GSS Pharma Bangalore
GSS Pharma Bangalore hiring Assistant Manager Pharmacovigilance. Pharm D/M.Pharm with 4–5 yrs experience. Apply now.
GSS Pharma is hiring an Assistant Manager for its Pharmacovigilance division in Bangalore. This role suits professionals with 4–5 years of experience in case processing, literature monitoring, safety signal evaluation and global PV documentation. Candidates must be comfortable navigating EU and international PV regulations, XEVMPD updates, RMP drafting and end-to-end safety compliance.
Company Overview
GSS Pharma Pvt. Ltd. is an established pharmaceutical services organisation supporting global safety operations, regulatory functions and medical affairs. The company provides pharmacovigilance services to international clients with a strong emphasis on data accuracy, compliance and inspection readiness. Its PV team handles safety monitoring, case management, literature screening and report preparation across multiple therapeutic areas.
Working at GSS Pharma offers exposure to international PV workflows, ICH/GVP/MHRA guidelines, and structured documentation practices essential for regulatory submissions and ongoing safety monitoring.
Job Role & Responsibilities
Assistant Manager – Pharmacovigilance
Key responsibilities:
- Review and validate literature abstracts and full-text articles; process relevant safety information into the safety database.
- Manage XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) entries and update EVWEB with SmPC, PIL and product information changes.
- Prepare Signal Detection Reports and Addendum to Clinical Overview (ADCO) based on emerging data trends.
- Draft and update Risk Management Plans (RMPs) in compliance with EMA GVP guidance.
- Review SmPC and PIL content against reference product information for accuracy.
- Monitor global safety updates and track safety signals for assigned client products.
- Ensure strict adherence to SOPs and PV regulations while meeting project timelines.
Core expectations:
- Strong understanding of GVP modules and global PV regulatory frameworks.
- High accuracy in literature assessment and safety narrative preparation.
- Ability to coordinate with medical reviewers and regulatory colleagues.
Eligibility / Qualifications
Required education: Pharm D / M.Pharm
Experience: 4–5 years in Pharmacovigilance with proven exposure to:
- Literature screening and case identification
- XEVMPD/EVWEB management
- RMP, ADCO and signal reports
- Safety intelligence and regulatory updates
Technical skills and competencies:
- Familiarity with safety databases and document management systems
- Good understanding of EU requirements for SmPC/PIL
- Strong analytical and documentation skills
- Clear written communication for regulatory documents
Relevant courses (comma-separated): Pharm D, M.Pharm Pharmacology, PG Diploma in Pharmacovigilance, Certificate in Signal Detection, Advanced Drug Safety Training, MSc Clinical Research
Location & Salary
Location: Bangalore (onsite)
Salary: Competitive, based on PV expertise, literature screening accuracy and XEVMPD experience.
Application Process
Interested candidates may send their CVs to:
Application tips:
- Highlight your experience in literature monitoring, RMP drafting and XEVMPD updates.
- Include specific examples of safety documents you have authored or contributed to.
- Ensure your CV reflects compliance-focused experience and global PV guideline exposure.
Why This Role Matters — EEAT Alignment
Pharmacovigilance professionals ensure medicinal products remain safe throughout their lifecycle. This role contributes directly to global patient safety through literature surveillance, signal detection and safety document preparation. Demonstrating verifiable experience in PV processes strengthens EEAT signals and positions candidates as credible safety professionals.
High-value keywords naturally included: pharmacovigilance jobs, drug safety jobs, signal detection, RMP writer, XEVMPD updates, EU pharmacovigilance compliance, safety database management, PV literature screening.
FAQs
Q: Is literature screening experience mandatory?
Yes. This role requires routine review of abstracts and full-text articles.
Q: Do I need experience with XEVMPD/EVWEB?
Yes. Hands-on XEVMPD updates are required.
Q: Can candidates with clinical research backgrounds apply?
Only if they have substantial PV experience.
Q: Is remote work available?
Role requires onsite work in Bangalore.
Q: What documents should I submit?
Updated CV, summary of PV experience and any training certificates.
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| Company | GSS Pharma Pvt. Ltd. |
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| Vacancies | Assistant Manager – Pharmacovigilance |
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| Required Education | Pharm D, M.Pharm |
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| Experience | 4–5 years in Pharmacovigilance |
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To apply for this job email your details to shilpa.a@gsspharma.com
