Medical Science Liaison (Msl)Oncology / Breast Cancer - Spain

Sponsor Dedicated Assoc Dir, Drug Safety & Risk Management - Home Based EMEA

Updated : March 3, 2025

Location : Spain-Europe - ESP-Home-Based (Madrid)

Job ID : 25001913

Sponsor Dedicated Associate Director, Drug Safety & Risk Management - Home Based EMEA

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job responsibilities

1. Provides strategic expertise to product teams and drives the execution of Risk Management (RM) activities included within RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety.
2. Collaborates in the development of innovative methods to develop the next generation for Risk Management Sponsor team.
3. Partners with the Risk Assessment Management Head to instate and maintain processes and changes.
4. Champions for managing and building the risk management knowledge for the organization.
5. Provides expertise regarding RMP requirements and implementation for pre-marketed and post-marketed drug products.
6. Recommends appropriate risk mitigation options for drug related safety issues, taking into account the benefit-risk profile of the drug, and approaches used for other products internal and external to the Sponsor.
7. Reviews RMP assessment reports to determine if modifications are required.
8. In collaboration with Risk Assessment management Head, develops / evolves / implements best practices in risk management planning, including risk communication, risk minimization and in benefit / risk assessment methodologies.
9. Supports with strategic guidance for risk management planning, considering local regulatory requirements, risk management best practices, and product specific risk profile, and development and implementation of RMP initiatives for products within the Sponsor portfolio.
10. Acts as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP and provides periodic updates regarding the status of implementation to the RMC.
11. Leads Product risk management using effective leadership and process management techniques.
12. Manages supplier performance / delivery relative to defined and agreed upon SOW; supports managing day-to-day supplier communications.
13. Provides regular reporting on all aspects of RMP milestones / performance per specific targets as defined by key performance indicators (KPIs) and / or regulatory commitments through maintenance and presentation of project performance dashboards.
14. Creates / maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans / milestones, progress reports, activity logs and deliverables, i.e. RMP submissions.
15. Updates / maintains assigned project related documentation as per defined in risk management processes and file structure on designated system.

Qualifications

What we’re looking for

1. Advanced degree preferred (Pharm.D, or Ph.D, or equivalents).
2. Senior Manager level - Minimum 5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance with a clear focus on drug safety risk management.
3. Director level - Minimum 10 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance with a clear focus on drug safety risk management.
4. Knowledge of global safety regulations and guidelines, or equivalent.
5. Demonstrated experience in global drug safety risk management planning activities and generating RMPs.
6. Demonstrated strength in analytical skills and attention to detail.
7. Demonstrated strength in oral / written communication, negotiation, and interpersonal skills.
8. Demonstrated organizational / project management skills.
9. Familiarity with management of performance metrics.
10. Project management certification (PMP) and Six Sigma Certification preferred.