Associate Medical Safety Director- Sponsor Dedicated (Home-Based)

IQVIA; Cataluña; On-site; EUR 110,000 - 150,000; Full time

Job summary

IQVIA seeks an Associate Medical Safety Director to oversee lifecycle safety activities for our portfolio. You will provide aggregate safety reviews, lead signal detection, and contribute to safety reporting across EU/US programs.

You will review data, guide risk management, support labeling, and act as an internal PV consultant. Strong communication and mentoring skills are essential.

Qualifications

• A medical degree from an accredited medical school.
• About three years of clinical practice with two years in pharma or related industry.
• Knowledge of federal/local regulations and GCP for clinical research safety.
• Maintain knowledge of assigned product portfolio and therapeutic area.
• Experience in signal detection, aggregate reports and risk management.
• Ability to synthesize and analyze data and communicate complex issues.
• Ability to set priorities, meet deadlines and work under pressure.
• Strong teamwork, initiative and adaptability with stakeholders.
• Ability to mentor colleagues and maintain collaborative relationships.

Responsibilities

• Provide aggregate reviews of safety information to oversee product safety.
• Lead signal detection and analysis, including strategy, frequency and timing.
• Contribute to EU/US safety reports and development safety documentation.
• Contribute to development risk management plans and risk evaluation strategies.
• Review safety data for trials and post-marketing setups for benefit-risk evaluation.
• Oversee safety for labeling development and updates.
• Support Integrated Safety Summary/CTD contributions.
• Perform medical review of AEs/ADRs and act as PV case processing consultant.
• Represent safety findings in internal/external meetings.
• Participate in Safety Governance meetings as needed.

Skills

Medical safety expertise

Regulatory knowledge

Signal detection

Data synthesis

Project management

Communication skills

Mentorship

Stakeholder management

Education

Medical degree

Job description

Our ever-growing Lifecycle Safety Medical team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.

Associate Medical Safety Director

Role responsibilities:

• Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile

• Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate

• Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports

• Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies

• Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up

• Providing safety oversight and contribution for label development, review, and updates

• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document

• Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams

• Representing safety and clinical data review findings during internal and external stakeholder meetings

• Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed

Do you have the skills, experience and qualification required for the role:

• A medical degree from an accredited and internationally recognized medical school

• Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience

• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process

• Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature

• Experience in Signal detection, Aggregate reports and Risk management.

• Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing

• Ability to establish and meet priorities, deadlines, and objectives

• Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.