Job Specific Skills:
- 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 process.
- 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, directly interacts with client, mentors others.
- Expert knowledge of coding with MedDRA and WHO drug dictionary.
- Proficient with QC process, writing tools.
- Proficient with templates, toolbars, and formatting.
- Proficient with MMS and client processes and training; 100% compliant.
- Proficient in understanding impact of updates in related deliverables.
- Independently managing/leading client meetings and CRMs for effective resolutions.




- Proficient with managing a project from start to finish and compliant with process; identifies efficiencies within dept processes.
- Proficient with handling client feedback with appropriate feedback

Job Requirements:
- College graduate in scientific, medical, clinical discipline or related field, or related experience, masters or PhD preferred.
- Minimum of 5 years experience in drug safety, pharmacovigilance, or similar field required.
- Expert knowledge of scientific principles and concepts.
- 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.
- Positive organizational and communication skills.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
- Familiarity with 21 CF

📌 Senior Drug Safety Associate (India)
🏢 MMSH Clinical Research
📍 India