Drug Safety Specialist, Belgium - L

CROMSOURCE), is searching for a Drug Safety Specialistto join a TOP pharmaceutical company in Belgium.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

The Pharmaceuticals Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Company products and will strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.

The MSO will report to the GMS Therapeutic Area Safety Head (TASH), and oversee the safety and benefit/risk assessment of assigned products within the TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit-risk assessment of assigned products within the TA. The MSO will communicate potential and known risks and changes to benefit/risk, when appropriate, to the TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Company products.

Main Job Tasks and Responsibilities:

Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS), as well as other activities related to managing the safety profile of assigned products (e.g., Program Safety Analysis Plan)

Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams

Anticipate safety concerns and influence other relevant functions including Clinical and Medical Affairs teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.

Be an active partner and core contributor of safety input to key regulatory or clinical documents including: Risk management plans, Clinical Trial, EAP and IIS Protocols

Informed Consent Forms (ICF), including Risk Language

• Safety Sections of Investigator’s Brochure (IB) and IB addenda
• Safety sections of Clinical Study Reports (CSR)
• Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings
• Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR), Development Safety Update Report (DSUR)
• Health authority queries
• Company Core Data Sheets (CCDS), US and EU prescribing information
• Signal Evaluations
• Defining the safety question or issue requiring medical safety assessment
• Developing the strategy for the safety review and analysis
• Interpreting results and determining the medical importance of question or issue
• Reviewing and approving (i.e., signatory) medical assessment reports, e.g. ad hoc safety reports

DECISION-MAKING AND PROBLEM-SOLVING:

Takes a leadership role in influencing senior management and key stakeholders across the business to achieve strategic goals. Leads others by example in influencing internal and external partners; demonstrates openness and seeks to understand different perspectives; gains the trust of others; asserts personal ideas and opinions using persuasion to influence others; demonstrates excellent negotiation skills. Gathers diverse viewpoints; proactively influences others appropriately across departments, functional areas, and with external partners.

Is viewed as a trusted partner across the business and with internal and external therapeutic area experts; anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances and coalitions. Uses an active network of relationships to achieve goals; fosters teamwork within own department or function, as well as across departments or functions; proactively addresses organizational barriers to enhance team effectiveness; leads the development of productive relationships among senior leaders and across organizational boundaries. Proactively maintains relationships with internal and external business partners across departments and functions; contributes actively to the effectiveness of cross-functional teams; capitalizes on existing structures and procedures for effectively engaging with partners.

Global Safety Strategy & Risk Management is a functional area within the Global Medical Organization.

Contacts Inside the Company:

• All Clinical Therapeutic Areas
• CSO
• CMO, Pharma
• QPPV Pharma
• Medical Safety Officers and Scientists in Global Safety Strategy & Risk Management (GSSRM)
• Other groups within GMO, including Medical Analytics & Safety Surveillance (MASS), GMS Operations (GMSO), Compliance Standards and Analytics (CSA) and Alliance Management
• Epidemiology
• Strategic Product Development
• Business Development
• Global Regulatory Affairs and Global Labeling
• Global / Regional Medical Affairs
• CDOs, including Biostatistics and Regulatory Medical Writing

Contacts Outside the Company:

• Clinical and Epidemiology Consultants and Advisors
• Regulatory Agencies
• Development Partners and Potential Partners
• Business Partners
• CROs

Education and Experience:

• Physician (MD or equivalent), generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)
• Board Certification (if US) preferred
• Medical specialization preferred
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience
• Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred
• Ability to influence, negotiate and communicate with both internal and external stakeholders
• Experience with Health Authority presentations is preferred
• Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans
• Able to plan work to meet deadlines and effectively handle multiple priorities
• Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
• Fluent in written and spoken English
• Proficiency in Word and PowerPoint is desired

Specific Role Requirements and Skills:

• Ability to effectively and strategically lead global cross-functional teams
• Connect, collaborate and build consensus across relevant functions
• Ability to think strategically, has a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business
• Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.

The Benefits of Working for TalentSource in the UK

• Pension contribution
• Life assurance
• 25 days holiday
• Child care vouchers
• Eye test vouchers
• Seniority bonus
• Car allowance for defined roles
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement
• Excellent work-life balance

The Application Process:

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who are CROMSOURCE:

CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

By joining our client teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Keywords:Drug Safety Specialist, Safety, CRO, Pharmaceutical, Medical Device, Risk Management