System Engineer Microsoft 80 – 100%

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

1. Responsible for leading and driving safety strategy for the development and maintenance of assigned products.
2. 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.
3. 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.
4. Establish strong relationships with important stakeholders in the Company in relation to B / R balance discussions and management.
5. 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.
6. Responsible for leading all interactions regarding product safety issues with Organon governance committees and regulatory agencies.

GPSS

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.

Health Authority interaction:

1. Manage the timely authoring of high-quality aggregate safety reports (ASR), response to questions (RTQ) and other scientific reports.
2. Ensuring proper scientific reflection of the B / R balance in periodic safety update reports as well as Risk Management Planning.
3. Measuring effectiveness of additional risk minimization activities.
4. Active role in preparing expert reports as appropriate and preparing safety regulatory files e.g., health authority responses.
5. 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.

Tasks

1. Manage the review of worldwide reports on adverse events including confirming causality assessments.
2. Timely authoring of high-quality aggregate safety reports.
3. Liaise with Regulatory department with evaluation of B / R and / or safety profile of product to update regulatory documents.
4. Supports safety trainings for new staff, Pharmacovigilance staff as well as refreshers.
5. Implementation of documentation necessary for pharmacovigilance like Risk Management Plans, etc.
6. Drug Safety Monitoring, Review of signal detection listings and escalating drug safety issues for further investigations in a timely manner.
7. Ensures safety tasks in clinical trials (including Protocol review, SUSAR, ASR / DSUR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulations.
8. Provides support in checking or preparing expert reports as appropriate and preparing safety regulatory files.
9. Signal detection and Benefit / Risk evaluation including initiating appropriate measures e.g., preparing decision-making board or committee presentations, change control of SmPC, risk management plan and resulting actions plans.
10. Creation and update of Risk Management Plan (including core RMP).
11. Active involvement in and oversight over TA related PASS / PAES or other safety studies.
12. Review of Medical / Clinical Safety related SOPs, “Dear Investigator / doctor letters”, if appropriate.
13. Organizes, in close collaboration with Clinical Operations and Clinical Development, the exchange of all safety relevant information between the GPSS Organon and involved CROs for all clinical development projects.
14. Review / preparation of, in close collaboration with Clinical Operations and involved CROs, for the f individual safety reports (SUSARs) and reports of aggregated clinical data (Annual Safety Reports / Developmental Safety Update Reports) according to legally required timelines to Health Authorities, Ethical Committees and external Safety Review Boards.
15. Data unblinding whenever appropriate and data reconciliation of clinical safety data entered into the Organon safety database after finalization of a clinical development project.
16. Support Clinical Development / Regulatory Affairs / Affiliates on ad hoc questions concerning medical / clinical safety (expert reports, regulatory dossiers).
17. Drug Safety related inputs into study protocols, study reports, informed consent forms and SmPC / Patient Leaflet.
18. Involvement in the correct communication and information on drug safety topics, in particular drug safety review of promotional and medical affairs materials.

Required Education, Experience and Skills

1. 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.
2. Ten plus years of experience in the pharmaceutical industry.
3. Five to ten plus years of experience in drug safety and pharmacovigilance in a global environment.
4. Extensive knowledge and understanding of PV deliverables, standards and processes at global level.
5. Knowledge and experience in Pharmacoepidemiology.
6. Experience with Benefit-Risk profile process implementation data analysis, signal management and benefit / risk monitoring, evaluation and B / R balance assessment.
7. Comprehensive knowledge of pharmacovigilance and clinical trial (ICH / GVP / GCP) legislations and the relevant Regulations governing Pharmacovigilance globally.
8. Experience in Pharmaceutical Medicine, particularly Clinical Research, and / or experience in Clinical Pharmacology.
9. Very good scientific, pharmaceutical and medical knowledge.
10. Excellent verbal and written communication skills, analytical skills as well as demonstrated leadership skills and are able to become quickly a valued and esteemed senior member of our interdisciplinary teams.
11. Able to build and maintain good relationships with a strong customer focus.
12. 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.
13. Attitude and behavior are congruent with the Company values (respect, teamwork and entrepreneurship).
14. Concern for standard and take a thorough approach, with high attention to detail.
15. Think and influence conceptually, strategically and rationally.
16. Interpersonally aware and culturally sensitive, with the ability to work in highly networked organizations with many partners.
17. Effectively able to plan and prioritize workload, with an accurate sense of urgency.
18. Able to interpret and apply global drug safety regulations and demonstrate a proactive attitude.
19. Able to build a well-functioning team with high quality output and in good team spirit.
20. Experience managing people.
21. Experience in woman’s health is a plus.
22. Excellent leadership in matrix team setting.
23. Problem solving ability.
24. Analytical mind.
25. Can manage peaks in workload and time pressure.
26. Proactive and results oriented.
27. Team player.
28. High quality output mindset.
29. Fluency in English.

Preferred Experience

Board Certification.

Who We Are :

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

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For more information about personal rights under Equal Employment Opportunity, visit:

Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and / or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver / parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

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