The Role
Provide medical and scientific judgment for aggregate safety reports (PBRER/PSUR), identify important safety concerns, review drafts and final reports, collaborate with Global Risk Assessment and report authoring teams, document revisions, and contribute to benefit-risk evaluations and HA feedback discussions.
Summary Generated by Built In
Job Description:
- Help guide report strategy, help determine important safety concerns and review medical and medical safety content that will be included or discussed in the report, including but not limited to safety signals, health authority requests, safety-related literature, adverse event case reviews, benefit-risk assessments, and overall medical assessments and conclusions.
- Work in collaboration with contributing team members, particularly with the reports assigned to the Global Risk Assessment and Safety Physician.
- Review all stages of the report that are assigned during the report authoring process, record their recommended revisions, and indicate completion of their reviews in the corresponding systems.
Key Responsibilities:
- Provide medical and scientific judgment in the evaluation of data pertaining to the efficacy and safety of Client products including, but not limited to, PBRER-PSURs and benefit-risk evaluations
- Review and contribute to strategy discussions, including determination of the important safety concerns and review of draft/final data, HA feedback topics, signals, and benefit-risk evaluation.
- Coordinate with Global Risk Assessment and Safety Physicians regarding PBRER steps and hand-offs and collaborate with other members of the report authoring team.
- Review the drafts and final reports as assigned and provide feedback, which may include pre-initial, drafts, drafts, final drafts, and final reports as assigned.
Experience/Qualifications:
- Requirement: Medical Physician
- Technical Skills: the ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential.
- Attention to detail: diligence in record-keeping and records organization, ability to manage high workload and critical issues, computer literate and proficiency in MS Office applications.
- Interpersonal skills: team player, displays initiative, strong communication, and presentation skills.
- Internal and external networking skills: strong collaborative and interpersonal skills, results-oriented and ability to independently create and deliver, ability to thrive in a global, cross-functional environment.
- At least one year of clinical experience or experience in pharmaceutical medicine, is preferred.
Experience and Skills:
- Proven expertise and 1-3 years of experience in pharmaceutical regulations and R&D processes is desirable.
- Data entry experience desired.
- Accountability for delivery of results.
- Decision making and problem-solving skills.
- Proactive approach/uses own initiative.
- Manages own work, able to prioritize, plan and organize work assignments and work under strict timelines
- Ability to follow guidelines, working practices etc.
- Experience of working with SOP/WI preferred
- Quality oriented, with attention to detail/accuracy.
- Flexibility/Adaptability.
- Positive attitude.
- Good team player.
- Ability to work independently and to collaborate.
- Good written and verbal communication skills.
- Understanding of medical terminology.
- Ability to summarize medical information.
- Awareness of global culture
Skills Required
- Medical Physician
- Ability to analyze, interpret, and present complex scientific and safety data (oral and written)
- Proficiency in MS Office applications
- Diligence in record-keeping and records organization; attention to detail and quality orientation
- Strong written and verbal communication and presentation skills
- Ability to summarize medical information and understand medical terminology
- Team player with strong collaboration and interpersonal skills; ability to work independently
- At least one year of clinical experience or experience in pharmaceutical medicine
- Proven expertise and 1-3 years of experience in pharmaceutical regulations and R&D processes
- Data entry experience
- Experience working with SOPs / Work Instructions (WIs)
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
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Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
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Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
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Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
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The Company
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
