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Please Note: The final title for this position will be determined based on the successful candidate's experience, background, and qualifications.

Roles and Responsibilities

- Lead and oversee global post-marketing case processing activities from intake through reporting and case closure
- Develop and maintain pharmacovigilance workflows, procedures, and work instructions as related to post marketing case processing
- Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs
- Proficient in ICH E2A, E2B(R3), and E2D guidelines
- Proficient in Pharmacovigilance quality systems
- Maintains an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial processes




- Independent Project lead, SME; provides strategic narrative development internally and externally, directly negotiates with client
- Process cases independently, understands steps involved with case processing. Leads creation/updates of high-quality deliverables
- Extensive experience working within a safety database and directly interacts with clients. Expert knowledge of coding with MedDRA and WHO drug dictionary

- Proficient in understanding impact of updates in related deliverables
- Independently managing/leading client meetings and CRMs for effective resolutions; provides mentorship to others
- Proficient with managing a project from start to finish and compliant with process; provides mentorship to others; identifies efficiencies within department processes

Requirements

- College graduate in scientific, medical, clinical discipline or related field, or related experience, masters, PharmD, or PhD preferred
- Minimum of 7 years’

experience in drug safety, pharmacovigilance, or similar field required

- Expert knowledge of scientific principles and concepts.
- Expertise in using drug safety databases
- Own and drive end-to-end process development, implementation and continuous improvement
- Reputation as emerging leader in field with sustained performance and accomplishment
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

📌 Associate Manager, Pharmacovigilance| Post-Marketing Case Processing| Hybrid, Bangalore (Bengaluru)
🏢 MMS
📍 Bengaluru