Pharmacovigilance Physician
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Pharmacovigilance Physician reviewing safety cases, signals, and aggregate reports for Evestia Clinical, a global biotech-focused CRO. Providing medical oversight across clinical and marketed products.
Responsibilities:
- Perform medical review of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing projects
- Assess seriousness, causality, and expectedness/labeledness of reported events
- Review MedDRA and WHO Drug coding for adverse events and concomitant medications
- Author medical assessments, company comments, medical summaries, and safety-related queries
- Review cumulative analyses of similar adverse events, including Analysis of Similar Events (AOSE)
- Provide medical support, guidance, mentoring, and training to the pharmacovigilance team
- Review scientific literature to identify potential safety signals or valid ICSRs
- Provide medical advice, data interpretation, and strategic guidance to internal departments, clients, and external partners
- Support responses to regulatory authority requests, inspections, sponsor audits, and safety inquiries
- Review and approve periodic safety reports, including PBRERs, PSURs, and DSURs
- Participate in signal detection, signal validation, and signal assessment activities
- Contribute to benefit-risk assessments, Risk Management Plans, and Safety Management Plans
- Participate in or present safety data at Safety Management Committees, Data Safety Monitoring Boards, and sponsor safety governance meetings
- Provide occasional clinical medical monitoring support during peak workloads or team absences
- Assist investigators with protocol eligibility, safety concerns, and data management queries
- Review clinical trial data listings, laboratory reports, and subject profiles for medical accuracy and safety concerns
- Ensure pharmacovigilance and medical monitoring activities comply with ICH-GVP, ICH-GCP, FDA, EMA, SOPs, and client requirements
Requirements:
- Primary medical degree (e.g., MD, MBBS, MBChB, DO or equivalent) from an accredited medical school
- Active or previously held medical license/registration
- Minimum of 2 years of experience as a physician in the pharmaceutical industry or a CRO, primarily focused on Pharmacovigilance and Drug Safety
- Hands-on experience performing medical review of ICSRs
- Working knowledge of global drug safety and pharmacovigilance regulations, including ICH, FDA, and EMA
- Strong scientific, clinical, and analytical knowledge
- Ability to read, analyze, and interpret scientific and clinical data
- Excellent oral and written communication skills
- Proficiency navigating clinical and pharmacovigilance safety databases
- Ability to exercise independent medical judgment and make timely, evidence-based decisions
- Excellent cross-functional collaboration and communication skills
- Strong knowledge of MedDRA and WHO Drug coding dictionaries
Benefits:
- Collaborative and flexible working environment
- Opportunities for professional growth
- Supportive culture focused on wellbeing, personal development, and work-life balance
- Opportunity to influence patient safety on a global scale
- Meaningful work benefiting patients around the world
Similar Jobs
Medical Doctor, Weight and Men's Health
Medical Doctor providing telehealth consultations, diagnoses, prescriptions, and referrals for Australians through Eucalyptus's digital healthcare clinics. Flexible remote scheduling with a minimum of 15 hours weekly.
In-Home Physician
In-home physician conducting personalized health evaluations for Signify Health, part of CVS Health. Reviewing histories, performing exams, and connecting members to appropriate care.
In Home Health Physician – Part Time
Part-time physician conducting in-home health evaluations for Signify Health, part of CVS Health. Reviewing medical histories, performing physical evaluations, and identifying care gaps.
Telehealth Physician
Telehealth Physician evaluating members and overseeing care plans for Carewell’s caregiving and care navigation services. Building clinical protocols, escalation pathways, and quality standards.
Physician Advisor II
Physician Advisor leading medical-necessity reviews, utilization management, and documentation improvement for Med-Metrix. Mentoring advisors and managing healthcare client quality relationships.
Mental Health Reviewing Physician
Mental health physician reviewing IME and FFDE records for public-safety employees. Providing fit-for-duty recommendations to federal contracting representatives.
General Radiologist
Remote general radiologist interpreting overnight emergency, inpatient, outpatient, stroke, and cross-sectional imaging. Supporting Baptist Health South Florida hospitals and imaging centers.
In-Home Health Physician, Part Time
Part-time physician conducting in-home health evaluations for Signify Health, part of CVS Health. Reviewing medical histories, performing physical evaluations, and connecting members to appropriate care.
Pediatric Radiologist, PRN
Remote PRN Pediatric Radiologist providing diagnostic and interventional pediatric imaging for Nemours Children’s Health. Interpreting examinations through an integrated PACS and collaborating across multi-site teams.
Physician Advisor
Physician Advisor guiding utilization management, denials, and appeals for Ensemble’s healthcare revenue cycle management clients. Conducting hospital status reviews and peer-to-peer payor consultations remotely nationwide.
Physician Advisor
Part-time Physician Advisor guiding utilization management for Ensemble, a healthcare revenue cycle management provider. Reviewing hospital stays, conducting payer reviews, and supporting denials, appeals, and medical staff education.
Telehealth Physician, FT
Telehealth Physician delivering preventive and chronic care to Medicare seniors for Belle. Conducting routine virtual visits, managing care plans, and coordinating with integrated clinical teams.
Virtual Primary Care Physician
Virtual primary care physician delivering video and message-based care for One Medical, an Amazon healthcare company. Managing acute, chronic, and preventive visits remotely.
Virtual Primary Care Physician
Virtual primary care physician delivering evidence-based telehealth for One Medical, a technology-enabled healthcare provider. Managing acute, chronic, and preventive care while overseeing NP and PA colleagues.
Virtual Primary Care Physician
Virtual primary care physician delivering evidence-based telehealth for One Medical, an accessible primary care healthcare platform. Managing acute, chronic, and preventive visits remotely.
Virtual Primary Care Physician
Virtual primary care physician delivering video and messaging-based care for One Medical, an Amazon healthcare company. Managing acute, chronic, and preventive visits while overseeing NP and PA colleagues.
Urgent Care, Telehealth Physician
Telehealth physician delivering virtual urgent care and observation services for Devoted Health’s older members. Supervising advanced practice providers and coordinating comprehensive care remotely.
Obesity Medicine Physician – Part-time
Obesity medicine physician providing remote, evidence-based chronic weight-management care for Form Health’s telemedicine clinic. Collaborating with APPs and dietitians while managing complex patient treatment.
Obesity Medicine Physician
Obesity Medicine Physician delivering virtual evidence-based weight-management care for Form Health’s telemedicine clinic. Collaborating with APPs and dietitians on multidisciplinary patient treatment.
Endocrinology Physician
Endocrinologist providing remote obesity and diabetes care through Form Health’s multidisciplinary telemedicine clinic. Managing complex diabetic comorbidities, CGMs, insulin pumps, and APP collaboration.