Executive Director, Drug Safety

The Position

• Strategic leadership role accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio (medicinal products and/or medical devices), for post-marketing pharmacovigilance (PV) activities (including interventional and non-interventional studies) from a scientific perspective and safeguarding patient safety.

• Leading all interactions regarding product safety issues with Organon governance committees and regulatory agencies e.g., by active participation and contribution to amongst others the Organon Asset teams, Risk Management Safety Teams (RMSTs), Safety Review Committee (SRC), LEAD/LAST, NORSAP and other safety related decision-making governance bodies.

• Build strong relationships with the cross functional teams, to influence and ensure that the development-, regulatory and or medical strategy and procedures are aligned with the safety strategy as well as with company objectives.

• Ensure that the scientific safety assessment of assigned products is driven by comprehensive and customer-focused strategic patient safety expertise, for effective benefit-risk decision-making by guidance, expertise sharing, coaching and/or training of the Drug Safety Leads, Safety scientists leads and Safety Scientists.

• Business process ownership of assigned core safety science processes and liaison between the different GPSS teams for PV system implementation and maintenance as well as issue resolution.

• Line-Management, development of staff in the Safety Science Therapeutic Areas at the Global Pharmacovigilance and Safety Science (GPSS) Department.

Organizational Relationships

• Reporting to the Associate Vice President, Safety Science Lead, GPSS.

Responsibilities

• Responsible for leading and driving safety strategy for the development and maintenance of assigned products.

  • Ensures the scientific foundation of the Benefit-Risk profile of Organon products, risk communication, inclusion of complete safety information in company core safety documents as well as the compliance of company drug safety.

  • Fulfill a leadership role in Benefit-Risk Balance related decision-making boards and/or committees, teams (e.g., RMST, RDRC, SRC, NORSAP) and provide strategic input.

  • Establish strong relationships with important stakeholders in the Company in relation to B/R balance discussions and management.

• Will collaborate with appropriate cross-functional Organon departments (respectively partner companies) to ensure efforts are aligned to meet global risk management strategies for the product portfolio.

• Responsible for leading all interactions regarding product safety issues with Organon governance committees and regulatory agencies.

• Works closely with GPSS Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping to develop and align processes to support departmental objectives.

• Will lead and manage a team of safety physicians and scientists and has an oversight role for their products (if applicable also remote).

• Supporting Drug Safety Training for Organon staff (initial, refresher and continuous) and communication to ensure PV awareness and understanding.

• Ensuring ICH/FDA/EMA guideline compliance of company drug safety, monitor compliance and demonstrate compliance in audits.

• Liaise with other sections in GPSS (e.g., QPPV office, PV OPS, GQC, PV affiliate, SS BD) to streamline processes ensuring timely and high-quality data management, processing and output.

• Provide scientific expertise to organization in particular to interdisciplinary developmental teams as well as post-marketing teams.

• Manage the timely authoring of high-quality aggregate safety reports (ASR), response to questions (RTQ) and other scientific reports.

• Ensuring proper scientific reflection of the B/R balance in periodic safety update reports as well as Risk Management Planning.

• Measuring effectiveness of additional risk minimization activities.

• Active role in preparing expert reports as appropriate and preparing safety regulatory files e.g., health authority responses.

• Represent GPSS and safety topics in Health Authority meetings (e.g., scientific advice).

• Act as key-SME during inspections.

• Act as point of contact for safety related topics with partners and/or vendors (e.g., ASR vendor, signaling vendor).

• Ensures appropriate oversight of SS process related vendor activities.

• Providing expert input on and ensuring safety tasks in clinical trials (including protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms, investigator brochure, unblinding) are handled appropriately and in compliance with regulations as well the design of the study meets the needs for risk management and B/R balance activities.

• Ensure continuous safety profile monitoring by means of Signal detection and benefit/risk evaluations including initiating appropriate measures e.g. preparing safety review committee (SRC) presentations, change control of CCDS, CCSI, SmPC, updating risk management plan and resulting action and communication plans are in place for TA and products under responsibility. Escalate in timely manner.

• Active involvement in and oversight of PASS/PAES or other safety studies.

• Responsible for the oversight on outsourced resources assigned to safety science activities in his TA, including safety surveillance and aggregate reporting.

• Participate, if applicable, in external drug safety monitoring boards and/or advisory boards.

• Creation/authoring of Medical/ Safety related Procedural Documents.

• Special duties on assignment.

Required Education, Experience and Skills

• Medical Degree, ideally clinical experience as Specialist in woman’s health, internal medicine, cardiology, neuroscience or equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety.

• Ten plus years of experience in the pharmaceutical industry.

• Five to ten plus years of experience in drug safety and pharmacovigilance in a global environment.

• Extensive knowledge and understanding of PV deliverables, standards and processes at global level.

• Knowledge and experience in Pharmacoepidemiology.

• Experience with Benefit-Risk profile process implementation data analysis, signal management and benefit/risk monitoring, evaluation and B/R balance assessment.

• Comprehensive knowledge of pharmacovigilance and clinical trial (ICH/GVP/GCP) legislations and the relevant Regulations governing Pharmacovigilance globally.

• Experience in Pharmaceutical Medicine, particularly Clinical Research, and/or experience in Clinical Pharmacology.

• Very good scientific, pharmaceutical and medical knowledge.

• Excellent verbal and written communication skills, analytical skills as well as demonstrated leadership skills.

• Able to build and maintain good relationships with a strong customer focus.

• Able professionally and successfully represent the company on the Benefit-Risk related matters in front of Health Authorities or other important external organizations or events.

• Attitude and behavior are congruent with the Company values (respect, teamwork and entrepreneurship).

• Concern for standard and take a thorough approach, with high attention to detail.

• Think and influence conceptually, strategically and rationally.

• Interpersonally aware and culturally sensitive, with the ability to work in highly networked organizations with many partners.

• Effectively able to plan and prioritize workload, with an accurate sense of urgency.

• Able to interpret and apply global drug safety regulations and demonstrate a proactive attitude.

• Able to build a well-functioning team with high quality output and in good team spirit.

• Experience managing people.

• Experience in woman’s health is a plus.

• Excellent leadership in matrix team setting.

• Problem solving ability.

• Analytical mind.

• Can manage peaks in workload and time pressure.

• Proactive and results oriented.

• Team player.

• High quality output mindset.

• Fluency in English.

Preferred Experience

• Board Certification.