About the role
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.
Qualifications
- Requirement: Licensed Medical Physician
- Experience in Drug Safety and Pharmacovigilance (PV) Concepts, regulatory requirements, research principles, and safety data analysis.
- 1-3 years of experience in pharmaceutical regulations and R&D processes.
- 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.
- 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.
- 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