MMS is hiring for an Associate Manager – Pharmacovigilance (Post-Marketing Case Processing) position in Bangalore, India. The role focuses on leading global post-marketing pharmacovigilance operations, overseeing case processing activities, maintaining regulatory compliance, developing PV workflows, and managing client interactions.
The position is intended for experienced drug safety and pharmacovigilance professionals with strong knowledge of global PV regulations, safety databases, case processing, and quality systems.
Job Details
| Particulars | Details |
|---|---|
| Company | MMS |
| Job Title | Associate Manager – Pharmacovigilance |
| Specialization | Post-Marketing Case Processing |
| Job Category | Drug Safety |
| Job Type | Full Time |
| Job Level | Manager/Supervisor |
| Job Location | Bangalore, India |
| Work Mode | Hybrid |
| Required Experience | Minimum 7 years |
| Qualification | Scientific, Medical, Clinical or Related Discipline |
| Preferred Qualification | Master’s Degree, PharmD or PhD |
About MMS
MMS is a data-focused Contract Research Organization (CRO) supporting the pharmaceutical, biotechnology, and medical device industries.
The organization provides scientific solutions for complex clinical trial data and regulatory submission challenges. MMS has a global presence across four continents and is recognized as a Great Place to Work® Certified organization.
Key Responsibilities
- Lead global post-marketing case processing activities from case intake through reporting and closure.
- Develop and maintain pharmacovigilance workflows, procedures, and work instructions.
- Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs.
- Independently process pharmacovigilance cases and oversee case-processing activities.
- Lead the development and revision of high-quality PV deliverables.
- Develop safety narratives and provide strategic narrative support internally and externally.
- Manage client interactions, meetings, and issue resolution.
- Lead PV projects from initiation through completion.
- Manage and improve departmental processes and identify operational efficiencies.
- Mentor team members and provide subject matter expertise.
- Maintain an understanding of regulatory updates and their impact on pharmacovigilance deliverables.
Eligibility and Qualifications
Candidates applying for the Associate Manager – Pharmacovigilance position should meet the following requirements:
- Graduate degree in a scientific, medical, clinical discipline, or a related field.
- Minimum 7 years of experience in drug safety, pharmacovigilance, or a similar field.
- Master’s degree, PharmD, or PhD preferred.
- Hands-on experience with clinical trial and pharmaceutical development is preferred.
- Demonstrated experience managing pharmacovigilance projects and processes.
Required Skills and Technical Knowledge
Candidates should have expertise in the following areas:
Pharmacovigilance and Regulatory Guidelines
- ICH E2A
- ICH E2B(R3)
- ICH E2D
- Good Pharmacovigilance Practices (GVP)
- FDA requirements
- GCP requirements
- 21 CFR Part 11
Case Processing and Safety Databases
- Global post-marketing case processing
- Safety database operations
- Medical coding using MedDRA
- WHO Drug Dictionary
- Safety narrative writing
- Pharmacovigilance quality systems
Quality and Process Management
- SOP development and revision
- PV workflow development and implementation
- Process improvement and continuous improvement
- ISO 9001 and ISO 27001 familiarity
Leadership and Client Management
- Independent project management
- Client meeting management
- Client relationship management
- Team mentorship
- Problem-solving and communication skills
– Proficiency in Microsoft Office applications.
