Senior Medical Reviewer Pharmacovigilance INDIA

MMS Holdings Inc; Hinoba-an; Sur place; PHP 900 000 - 1 500 000; Plein temps

Résumé du poste

MMS Holdings Inc. is seeking a Medical Reviewer/Safety Specialist to lead pharmacovigilance activities in a global CRO environment in the Philippines.

You will oversee signal detection, safety surveillance, and medical review of complex data, ensuring regulatory compliance across trials. Ideal candidates hold an MD or equivalent, with 5+ years in pharmacovigilance, strong communication skills, and hands-on experience with MedDRA, WHO Drug, and related safety deliverables.

Qualifications

• Minimum of 5 years’ experience in pharmacovigilance, safety signal detection and aggregate report review/authoring or as a Safety Specialist, Medical Reviewer or similar field required.
• Expert knowledge of scientific principles and concepts.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Responsabilités

• Expertise in end-to-end signal management and safety surveillance activities
• Experience with signal management applications
• Represent the Company in signal management and safety surveillance interactions internally and externally
• Perform and provide oversight to signal detection activities to ensure compliant processes
• Maintains an extensive understanding of regulations and guidance as they pertain to medical review; mentors others and updates MMS and clients on related regulatory updates.
• Proficient with various tools, such as MedDRA, WHODRUG, Bradford Hill Criteria, RSI, etc., used during medical review.
• Proficient with medical reviewer and client processes, including QC process.
• Proficient with medical review of safety deliverables for inclusion of relevant medical information, suggesting deletion of irrelevant information, and to ensure it makes sense from a medical perspective.
• Proficient in coding of clinical database data using MedDRA (Adverse events, medical history) and WHO Drug dictionary (concomitant medications).
• Proficient in safety analysis process used to identify potential new safety signal, aggregate report authoring and experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical information (e.g., DSURs, PADER, PBRER).
• Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
• Reviews individual case safety reports (ICSRs) from clinical trials, literature, and other sources
• Proficient in understanding impact of updates in related deliverables.
• Proficient with managing client meetings, feedback and SRMs.
• Proficient with identifying and mitigating project risk, including assessing client gaps.
• Provides mentorship to others on medical review, safety signalling and pharmacovigilance.
• Experience in medical monitoring preferred

Connaissances

Pharmacovigilance

Signal detection

Medical review

Client interaction

Regulatory knowledge

MS Office

Formation

MD degree

Outils

MedDRA

WHO Drug dictionary

Bradford Hill Criteria

Description du poste

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Roles & Responsibilities

• Expertise in end-to-end signal management and safety surveillance activities
• Experience with signal management applications
• Represent the Company in signal management and safety surveillance interactions internally and externally
• Perform and provide oversight to signal detection activites to ensure compliant processes
• Maintains an extensive understanding of regulations and guidance as they pertain to medical review; mentors others and updates MMS and clients on related regulatory updates.
• Proficient with various tools, such as MeDRA, WHODRUG, Bradford Hill Criteria, RSI, etc., used during medical review.
• Proficient with medical reviewer and client processes, including QC process.
• Proficient with medical review of safety deliverables for inclusion of relevant medical information, suggesting deletion of irrelevant information, and to ensure it makes sense from a medical perspective.
• Proficient in coding of clinical database data using MedDRA (Adverse events, medical history) and WHO Drug dictionary (concomitant medications).
• Proficient in safety analysis process used to identify potential new safety signal, aggregate report authoring and experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical information (e.g., DSURs, PADER, PBRER).
• Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
• Reviews individual case safety reports (ICSRs) from clinical trials, literature, and other sources
• Proficient in understanding impact of updates in related deliverables.
• Proficient with managing client meetings, feedback and SRMs.
• Proficient with identifying and mitigating project risk, including assessing client gaps.
• Provides mentorship to others on medical review, safety signalling and pharmacovigilance.
• Experience in medical monitoring preferred

Job Requirements

• Medical Degree required (MD or equivalent), board certification preferred.
• Minimum of 5 years’ experience in pharmacovigilance, safety signal detection and aggregate report review/authoring or as a Safety Specialist, Medical Reviewer or similar field required.
• Expert knowledge of scientific principles and concepts.
• 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.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process