Medical Review and Device Safety Lead

The Position

The Medical Review and Device Safety Lead provides leadership in the areas of PV operations, medical assessment, device PV regulations, first-line signal detection, and innovation. The Medical Review and Device Safety Lead oversees the implementation and monitoring of processes to ensure operational and scientific consistency of the in-line medical assessment of individual case safety reports (ICSRs) in accordance with global PV regulations. The Medical Review

and Device Safety Lead is accountable for the implementation of necessary processes to ensure compliance with global PV regulations related to medical assessment and device safety. This role is responsible for directing and overseeing a PV Medical Review team (in-house and outsourced), which supports these processes working cross-functionally to maintain standards for pharmacovigilance activities to ensure patient safety.

Responsibilities

Contributes to the development of and maintenance of comprehensive and compliant medical review and medical assessment processes to

drive efficiency into the medical safety review business process, introducing automation where possible.

Ensures implementation of new or updated regulations and/or ICH Guidelines regarding in-line medical assessment to ensure regulatory compliance for individual case safety reports.

Provides in-line medical assessment of individual case safety reports in the context of the available safety data and the known safety profile to

assess expectedness and formulate a company statement and a causality assessment as per-timelines determined by OARS workflow. Provides in-line medical assessment of harm or potential harm associated with device or device-constituent to support individual case safety report (ICSR) reportability determination as per-timelines determined by OARS workflow.

Serves as the primary point of contact for in-line medical assessment of individual case safety reports and as subject matter expert for these topics during audits and inspections.

Provides device legislation expertise in relation to medical review and medical assessment and reporting responsibilities.

Consults with TA lead Clinical Development Safety and/or Clinical Research as needed for cases requiring additional safety or clinical subject matter expertise.

Escalates potential safety issues to the attention of the Head Medical Safety Excellence and Safety TA Leads.

Develops, maintains, and captures metrics and Key Performance Indicators (KPI) to track quality and compliance with PV regulations and timelines in collaboration with the relevant quality and compliance teams.

Contributes to the preparation and responses to Regulatory Agency Inspections as well as internal and external audits.

Provide input and review of responses to regulatory agency questions with regards to inline medical assessment of ICSRs Provide expert guidance on relevant PV activities outlined by procedures (SOPs, user

manual, etc.).

Lead and/or participate in cross-functional projects as the medical safety & device subject matter expert, contributing to continuous process improvement of ICSR assessments.

Collaborate internally and externally on processes that ensure compliance with local and global PV regulations.

Assess and implement emerging regulations to ensure global alignment of in-line medical assessment of individual case safety activities and processes.

Participate in audit and/or inspection readiness activities and assists during the audit or inspection preparation, execution and CAPA resolution phase as needed as Subject Matter Expert.

Participate in external benchmarking and industry working groups to drive change across the industry.

Generate and track relevant metrics and KPIs.

Required Education, Experience, and Skills

• Accurate and detail oriented.

• Decisive with sense of urgency.

• Shows initiative and proactive problem-solving approach.

• High ethical standards, attitude, and behavior, congruent with the company Values.

• Interpersonally aware and culturally sensitive.

• Work in a highly networked organization with many partners.

• Adequate coping mechanisms to deal with stress and peak workloads.

• Problem solving, conflict resolution and critical thinking skills.

• Excellent presentation, writing and communication skills.

• Proficient in basic Office 365 suite applications.

• Good computer literacy with experience with safety databases (Argus preferably).

• Ability to consistently deliver on deadlines, with high standards for quality and sense of urgency.

• Fluency in English.

• Collaborative and team orientated.

Preferred Education, Experience, and Skills

• A minimum 7 years of work experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities.
• Minimum of 5 years’ experience supervising/managing/leading.
• Experience with vendor oversight.
• Strong knowledge of clinical research process, pharmacovigilance processes and end to end process of individual case safety reporting for both clinical research and Post Marketing environments.
• Strong knowledge of global PV regulations, in-depth understanding of business process, as well as safety systems for collections of adverse experiences.
• Experience in global Medical Device regulations and device safety monitoring.
• Experience working cross culturally and actively supporting diversity.
• MD or equivalent Ex US degree in Medicine with several years of pharmacovigilance and/or clinical experience exercising medical judgment as a physician ideally specialist in Woman’s Health, Internal medicine, or Pharmaceutical Medicine. Post-graduate qualifications in other areas are a plus.

Secondary Job Description

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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

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:

Relocation:

VISA Sponsorship:

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R525763