Director, Medical Safety Science
Department Name: Medical Safety
Objective of Position
The Director Medical Safety Science encompasses a key role in setting and executing on departmental strategy and in managing the day-to-day functioning of the Drug Safety & PV department. This role collaborates with colleagues and vendors representing Clinical Science, Clinical Operations, Biometrics, Regulatory & QA and Legal.
Essential Duties/ Responsibilities
- Ensures that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures
- Performs Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database
- Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as appropriate
- Liaises with assigned Physicians in Drug Safety, Medical Monitors in Clinical Development and others to ensure that appropriate medical review and assessment is provided for assigned case reports
- Leads bi-weekly clinical data review in collaboration with Clinical Development, Data Management and Clinical Programming
- Manages communications with partner companies, collaborative sponsors & respective CROs regarding the evaluation and processing of case reports
- Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems
- Is the key point of contact for investigational product complaints after receipt of initial complaint providing assessment of any SAEs related to the product complaint and sends to Acerta Quality Assurance
- Assists Medical Director(s) in the analysis, identification and reporting or possible trends and concerns re: Acerta-Pharma products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
- Manages the planning and preparation of the adverse events section of protocols and informed consents for clinical studies
- Participates in the negotiation of safety exchange agreements (PVAs) with license partners and distributors in support of process definition, monitoring and other roles as required by drug safety to perform the drug safety mission
- Participates in the development and management of Data Monitoring Committees, including development of DMC Charters and QA/QC of required line-listings and aggregate summaries of applicable safety data DB
- Manages activities for Investigator Sponsored Trials (ISTs), including review of protocols, informed consents, IST contracts, and appropriateness of safety data received from IST trials
- Ensures that the reconciliation of applicable safety DB data with external groups such as the DM staff for clinical studies; Drug Safety personnel from partner companies, etc. is governed by Acerta Pharma SOPs
- Oversees the preparation of ASURS, DSURs, IND Annual Reports, PSURs/PBRERs and other global periodic safety reports
- Participates in the development and review of appropriate safety sections of IBs, CSRs, ISS, & NDAs
- Manages the process for identifying, evaluating, and selecting outsourcing vendors ( CROs, Call Centers, safety DB vendors)
- Ensures training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs
- Reviews aggregate safety data from the clinical DB in support of Data Monitoring Committee meetings, interim analyses or final DB lock
- Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems
- Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development
- Participates in health authority interactions (both written and verbal) and inspections regarding safety and risk management
- Ensures that all appropriate company personnel and external groups in PV and Drug Safety are aware of principles, SOPs and policies
- Participates in the development and management of departmental budget
- Ability to travel both domestically and internationally (<30%)
- Minimum 12 years of drug safety, clinical research, or healthcare related experience
- A minimum of 2 years must be derived from pharmaceutical industry experience directly related to adverse event reporting from clinical trials
- Global experience is preferred. Oncology experience is a plus
- Detailed knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
- Minimum 5 years industry experience
- MD degree required
- Masters in life sciences; PharmD; Nursing /RN. Preferred MD.
To apply for this position, please send your resume to email@example.com
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. This document may be changed at management’s discretion.
Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment, and all qualified contractors for Acerta Pharma contract positions, without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Acerta Pharma only employs individuals, and engages contractors, with the right to work in the country/ies where the role is based.
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