FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Director, Medical Safety Officer – Oncology
Johnson & Johnson. Assess the medical safety of assigned products and strategically lead cross-functional teams responsible for product safety and benefit-risk oversight .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical safety assessment, pharmacovigilance, and risk management, with a strong ability to lead cross-functional teams and communicate effectively with stakeholders. Proficient in evaluating safety data and contributing to regulatory submissions and clinical trial protocols.
Highest-signal resume keywords
Pharmacovigilance ExperienceClinical Medicine SkillsRisk Management PlansGood Clinical Practices KnowledgeMedical Oversight Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical Safety AssessmentDrug Development PrinciplesClinical Trial MethodologySafety Data EvaluationRegulatory SubmissionsRisk Mitigation StrategiesSignal DetectionSafety SurveillancePharmacology KnowledgeClinical Practice Experience
Soft Skills
Influencing StakeholdersStrategic ThinkingCollaborationNegotiationCommunication Skills
Tools & Technologies
WordPowerPoint
Certifications & Qualifications
Physician (MD or Equivalent)Board Certified/Board Eligible
Industry Keywords
PharmacovigilanceClinical ResearchMedical AffairsHealth Authority PresentationsGlobal Safety RegulationsREMSPBRERs/PSURsGood Clinical PracticesSafety Management TeamsClinical Trial Conduct
About the role
Key responsibilities & impact- Assess the medical safety of assigned products and strategically lead cross-functional teams responsible for product safety and benefit-risk oversight
- Represent Global Medical Safety as the product spokesperson regarding overall benefit/risk
- Report to the Product Safety Head, Cellular Therapy, Hematology and oversee safety and benefit/risk assessment of assigned marketed and clinical-development products
- Conduct proactive and timely assessments of safety data to characterize emerging and known safety profiles
- Communicate potential and known risks and benefit/risk changes to senior safety, medical, management, health authority, prescriber, and patient stakeholders
- Lead the design and implementation of risk mitigation strategies when appropriate
- Strategically lead Safety Management Teams for assigned products
- Lead safety surveillance, signal detection, risk management plans, REMS, and related safety-profile activities
- Provide medical and scientific expertise on Compound Development Teams and Clinical Teams
- Influence clinical protocol design to anticipate and mitigate safety concerns
- Contribute safety input to risk management plans, safety development plans, clinical trial protocols, informed consent forms, investigator brochures, clinical study reports, annual safety reports, integrated safety summaries, regulatory submissions, PBRERs/PSURs, health authority queries, and core data sheets
- Communicate medical safety and benefit/risk evaluation results to leadership and safety councils
- Participate in meetings with Health Authorities and external key opinion leaders
- Provide medical safety leadership on due diligence teams for licensing and acquisition opportunities
- Provide medical oversight to contractors and non-physician staff preparing written safety evaluations
- Define safety questions, develop review and analysis strategies, interpret results, determine medical importance, and review/approve medical assessment reports
- Align and improve common safety processes across Global Medical Safety therapeutic areas
- Assist with creating, reviewing, and implementing SOPs, work instructions, guidelines, documents, and safety/risk-management tools
- Lead or actively participate in department-wide initiatives
Requirements
What you’ll need- Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs, clinical) required
- Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience
- Board Certified/Board Eligible/equivalent preferred
- Medical specialization preferred
- Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred
- Ability to influence, negotiate and communicate with both internal and external stakeholders
- Experience with Health Authority presentations preferred
- Ability to lead global cross-functional teams effectively and strategically
- Ability to connect, collaborate, and build consensus across relevant functions
- Strategic thinking, global mindset, and big-picture orientation
- Ability to critically evaluate safety data from clinical trials, environment, literature, and other sources; assess clinical importance and strategic impact; and present findings clearly in writing and verbally
- Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in the US, EU, and globally
- Knowledge of clinical trial conduct and contributions to regulatory filings, PV documents, and risk management plans
- Ability to plan work to meet deadlines and handle multiple priorities
- Excellent verbal and written communication skills, including formal presentation skills
- Fluent in written and spoken English
- Proficiency in Word and PowerPoint desired
Benefits
Comp & perks- Inclusive work environment
- Equal opportunity employment
- Interview process accommodations for applicants with disabilities