Description:
The Director, Medical Safety (DMS) position is responsible for supporting the strategy, direction, and priorities of pharmacovigilance (PV) activities and is accountable for the overall safety profile and deliverables for assigned product(s).
The DMS will partner with internal stakeholders including the Head of PV on establishing NDA safety strategies. This individual will also support other investigational and marketed products as needed. This includes all pre- and post-marketing safety, supporting signal detection and risk management activities. This individual will also mentor Safety Scientist(s) and Medical Reviewer(s) supporting the assigned product(s), if applicable. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Requirements:

• MD or DO with at least 3 years of experience in international PV with relevant clinical experience considered.
• Mentor safety scientist(s) and medical reviewer(s) responsible for assigned product(s), as applicable.
• Must have experience in PV strategy and activities for a compound including the preparation of DSURs, PSURs, Company Core Safety Information (CCSI) and Risk Management Plans.
• Experience with the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience.
• Clinical development and post marketing experience required including involvement in the development of strategies, priorities for PV activities.
• Thorough knowledge of current US, Global, and ICH safety management and reporting regulations and guidelines.
• Worked with a drug safety database (ARGUS experience helpful) and have had responsibility for medical review of SAE reports.
• Strong working knowledge of MedDRA and WHODrug coding dictionaries.
• Excellent written and oral communication skills in the English language.
• Ability to perform and present Safety Analyses to Senior Management.
• Resourcefulness and personal organization skills together with demonstrated cross- functional teamwork.
• Competent in Microsoft Word, PowerPoint, Excel.
• Ability to maintain an “inspection ready” environment.
• Strong attention to detail.
• Solid medical knowledge of methods to assess causality relationship between adverse events and investigational and marketed products.
• Relevant experience in the oncology therapeutic area, strongly preferred

• Work closely with the Head of PV to establish and support the strategy, direction, and priorities of PV activities and is accountable for the overall safety profile and deliverables of assigned product(s).
• Identification, analysis and reporting of possible safety trends and concerns with assigned product(s), including the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience, review of relevant literature articles, product quality complaints and non-clinical safety data.
• Research and carry out signal detection activities utilizing internal and external sources of investigational or marketed product safety data.
• Perform safety analyses and present these at cross-functional meetings and to Senior Management.
• Participation in and contribution to safety characterization during dose escalation and dose selection (dose optimization). This Is to be accomplished through active participation at study team meetings as the safety physician industry practice expert.
• Support the development, implementation and coordination of risk mitigation strategies (e.g., Risk Management Plans, REMS, Post-Marketing Evaluation Programs), to ensure the safe and appropriate use of Kumquat Biosciences products, in compliance with global legal and regulatory requirements.
• Lead the production of all relevant regulatory documentation (e.g., DSUR, PSUR) as well as support the production of clinical documentation (e.g., Protocols, IBs, ICFs).
• Lead PV responses to medical inquiries regarding safety issues, ad hoc requests from regulatory agencies, ad hoc requests to support CTAs with study sites, etc., as needed.
• Partnering with internal stakeholders on establishing safety strategies for NDAs, commercialization and post-market PV requirements.
• Mentoring of the Safety Scientist(s) and Medical Reviewer(s) supporting the assigned product(s), if applicable.
• Perform individual case review, provide a company comment as well as input into narratives, when necessary, provide any medical queries, and assign causality.
• Review AOSE and provide input into AOSE text and conclusions.

Requirements:

• MD or DO with at least 3 years of experience in international PV with relevant clinical experience considered.
• Mentor safety scientist(s) and medical reviewer(s) responsible for assigned product(s), as applicable.
• Must have experience in PV strategy and activities for a compound including the preparation of DSURs, PSURs, Company Core Safety Information (CCSI) and Risk Management Plans.
• Experience with the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience.
• Clinical development and post marketing experience required including involvement in the development of strategies, priorities for PV activities.
• Thorough knowledge of current US, Global, and ICH safety management and reporting regulations and guidelines.
• Worked with a drug safety database (ARGUS experience helpful) and have had responsibility for medical review of SAE reports.
• Strong working knowledge of MedDRA and WHODrug coding dictionaries.
• Excellent written and oral communication skills in the English language.
• Ability to perform and present Safety Analyses to Senior Management.
• Resourcefulness and personal organization skills together with demonstrated cross- functional teamwork.
• Competent in Microsoft Word, PowerPoint, Excel.
• Ability to maintain an “inspection ready” environment.
• Strong attention to detail.
• Solid medical knowledge of methods to assess causality relationship between adverse events and investigational and marketed products.
• Relevant experience in the oncology therapeutic area, strongly preferred.

Salary Description: $225k - $275