Assoc Medical Safety Dir Lisboa

Assoc Medical Safety Dir
Lisboa
Lisboa, Lisboa, Portugal

We are looking for an Associate Medical Safety Director to provide medical, scientific, and therapeutic expertise on pharmacovigilance services. This role involves participating in all aspects of the Medical Safety activities, such as:

1. Performing medical review and clarification of
   - related Adverse Events (AEs) and
   - marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summary.
2. Composing, editing, and medically reviewing Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements.
3. Serving as an internal consultant to pharmacovigilance case processing teams on projects.
4. Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile.
5. Providing coding review of AEs, past medical history, concomitant medications, or other medical data listings to verify and medically vet clinical data.
6. Representing safety and clinical data review findings during client meetings.
7. Providing medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, and US Periodic Reports.
8. Providing medical review and edits of Development Risk Management Plans, EU Risk Management Plans, or US Risk Evaluation and Mitigation Strategies.
9. Providing medical oversight for label development, review, and change.
10. Providing medical support and attendance at Data Safety Monitoring Board Meetings.
11. Attending and contributing to medical safety evaluation on Safety Monitoring Committees.

Do you have the skills, experience and qualifications required for the role?

1. A medical degree from an accredited and internationally recognized medical school.
2. Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry.
3. Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research, including safety and good clinical practice.
4. Knowledge of clinical trials and the pharmaceutical research process.
5. Experience in risk management, signal detection, and aggregate reports.
6. Ability to establish and meet priorities, deadlines, and objectives.
7. Demonstrated skills in providing consultation and advice on multiple assignments, as well as initiative and flexibility.
8. Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at IQVIA.