SENIOR DRUG SAFETY SPECIALIST SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Mai 29, 2025 - The Senior Drug Safety Specialist has extensive experience in pharmaceutical and biotechnology pharmacovigilance case processing, covering both clinical trial and post-marketing settings. This position is proficient in case assessment, MedDRA coding, narrative writing, quality review, and compliance with global regulations, including US, EU, AP, and LA guidelines. The senior specialist has strong analytical skills, knowledge of Argus, and the ability to manage multiple responsibilities while ensuring high-quality case processing and adherence to industry standards.

Essential Hard and Soft Skills for a Standout Senior Drug Safety Specialist Resume
  • Pharmacovigilance
  • Risk Management
  • Clinical Trial Monitoring
  • Regulatory Compliance
  • Safety Data Analysis
  • Adverse Event Reporting
  • Signal Detection
  • Medical Writing
  • Risk Benefit Assessment
  • Drug Safety Databases
  • Communication
  • Attention to Detail
  • Critical Thinking
  • Problem-Solving
  • Time Management
  • Collaboration
  • Adaptability
  • Leadership
  • Decision-Making
  • Conflict Resolution

Summary of Senior Drug Safety Specialist Knowledge and Qualifications on Resume

1. BS in Medicine with 6 years of Experience

  • Strong communication skills with multiple stakeholders
  • Have the ability to identify and troubleshoot issues
  • Previous leadership/support experience with internal and external parties
  • Experience in a safety/pharmacovigilance role ideally within a lead role
  • Strong leadership skills, enthusiasm, and drive.
  • Previous experience as a Supervisor or Lead role within a Drug Safety Operation
  • Experience in ICSR processing using validated Safety databases, preferably in Argus
  • Formal and current ICH GCP training.
  • Adaptable, influential motivated, and ‘hands-on’ mindset with experience in management.
  • Able to act as subject matter expert concerning Australian regulatory and EC Clinical trial safety reporting requirements
  • Sound knowledge of FDA and EMA regulatory and EC Clinical trial safety reporting requirements
  • Sound knowledge of MedDRA and WHO Drug coding.

2. BS in Toxicology with 10 years of Experience

  • Pharmacovigilance or clinical and/or medical research or equivalent experience.
  • Experience in and knowledge of drug safety databases (e.g., ARISg, Argus)
  • Experience in signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs
  • The ability to evaluate, interpret, and synthesize scientific data
  • Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
  • Knowledge of drug safety systems (e.g. ARISg and Argus)
  • Strong knowledge of current pharmacovigilance practices
  • Vendor management experience
  • Expertise in clinical trial and post-marketed pharmacovigilance
  • Understands key business drivers and uses this understanding to accomplish work
  • A strong understanding of processes, procedures, and systems used to accomplish the work and recognizes the downstream impact on other functional areas
  • Proficient with tools and processes that support work conducted by functional area
  • Strong communication, problem-solving, and analytical thinking skills
  • Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
  • Strong project management skills, and being a team player with the ability to function in a multi-disciplinary environment
  • Self-motivated, detail-oriented, and able to prioritize and plan effectively
  • Strong technical skills and software skills (i.e., MS Excel)

3. BS in Pharmacy with 7 years of Experience

  • Proven oncology work experience
  • Drug safety surveillance and/or pharmacovigilance experience or comparable relevant experience and training
  • Proficient with medical terminology
  • Safety database experience (with ARISg)
  • Medical writing experience with PSURs, DSURs, and SDEAs
  • Expert global knowledge of GCPs and regulatory requirements for SAE processing
  • Ability to coordinate complex global and domestic studies
  • Effective problem-solving ability and project management skills
  • Effective mentoring skills and ability to train and lead others
  • Knowledge of international safety reporting processing
  • Broad-based therapeutic knowledge
  • Excellent oral and written communication skills, with great attention to detail
  • Excellent analytical and technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.

4. BS in Pharmacology with 8 years of Experience

  • Hold healthcare certification (i.e., RN, RPh, PharmD, Physician’s Assistant, Nurse Practitioner, Respiratory Therapist, etc.).
  • Experience with post-marketing and/or clinical adverse events in the pharmaceutical industry including experience with a safety database.
  • Clinical/practical experience in a relevant clinical environment
  • Thorough knowledge of Global PV regulations and guidelines.
  • Knowledge of the clinical areas for which Mallinckrodt markets products.
  • Knowledge in the review and analysis of the medical literature.
  • Demonstrable skills in reviewing and summarizing medical records.
  • Excellent verbal and written communication skills including excellent telephone etiquette, and must be comfortable handling discussions on health and medical topics.
  • Strong experience in computer applications such as Microsoft Word, Excel, Microsoft Access, and PowerPoint, and a willingness to expand and increase competencies.
  • Extensive experience in reporting as well as managing adverse event reports.
  • Committed, self-motivated team player, with exceptional problem-solving skills
  • Ability to meet the demands of a position in a dynamic organization
  • Ability to operate independently by planning, scheduling, and arranging activities to accomplish objectives.
  • Ability to meet internally and externally required deadlines with outstanding organizational abilities

5. BS in Biomedical Science with 5 years of Experience

  • Pharmaceutical/biotechnology PV case processing experience, including clinical trial and post-marketing experience.
  • Global working experience
  • Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review, expedited report review and scheduling, and follow-up with reporters
  • Strong understanding of database functionality and business workflow to be able to perform root cause analyses and troubleshoot
  • Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
  • Understanding of Microsoft Office applications, specifically Excel and Word
  • Healthcare professionals with clinical experience
  • Experience working with Argus
  • Ability to independently manage multiple projects or responsibilities in addition to everyday case processing workload
  • Demonstrated initiative, teamwork, and accountability
  • Solid knowledge of global regulations and guidelines for drug development
  • Demonstrated analytical and statistical skills.
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