Position Title:
Director of Medical Safety
Reporting To:
Sr VP, Pharmacovigilance and Risk Management
Job Description:
The Medical Safety Officer is responsible for assisting clients with the safety strategy and all medical safety aspects of pharmacovigilance and medical risk management for assigned development, marketed products and clinical studies.
Responsibilities:
The general duties and responsibilities as they relate to case processing activities include but may not be limited to the following:
- S/he monitors and manages the ongoing safety profile of client products to maximize the understanding of risks and benefits for prescribers, patients, consumers and study subjects through review of all relevant pre? and post?marketing safety data, medical analysis and decision making.
- Activities include the oversight of the safety aspects for client’s clinical studies, development and maintenance of the Company Core Safety Information, development of ad hoc aggregate safety reports, contribution to and review of aggregate safety reports, development and conduct of signal detection activities and reports, safety sections of risk management plans, assessment of individual case safety reports and field alert reports.
- S/he works in close collaboration with client cross?functional teams and counterparts in regulatory labeling, clinical development, pre?clinical, manufacturing/quality, epidemiology, and other functional areas to identify, evaluate, and communicate safety issues.
- Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on product and project assignments, current development projects and the requirements within the organization as a whole.
- Work activities are conducted in compliance with all relevant global regulations, BioSoteria and client?specific SOPs.
- Perform signal detection exercises to monitor the safety profile of assigned pre? and post marketed products. Evaluates signals for evidence indicative of a drug relationship. Writes safety review documents and reports.
- Facilitates the preparation, review, approval, and distribution of the client’s Development and Company Core Safety Information for inclusion in IBs, Company Core Data Sheets and local labeling. Reviews any significant proposed label changes to determine whether they constitute a deviation from the CCSI and initiates appropriate action. Updates pre?marketing and postmarketing safety information and provides the justification documentation for any changes to IBs and CCSIs.
- Provides medical oversight for the safety aspects the client’s clinical trials including drafting and review of relevant safety chapters/text of key clinical trial documents such as informed consent, protocols (specifically inclusion / exclusion criteria and AEs of interest). Evaluates safety data generated in clinical trials. Participates in teams to provide medical leadership and development of risk management strategy. Provides medical safety interpretation of safety findings for clinical study reports, including final review of safety relevant adverse event coding for assigned projects and discusses, proposes, and communicates any revision(s) or additions. Ensures regulatory reports (e.g., clinical study reports, NDA, BLA) accurately reflect proper safety interpretation of the clinical study findings. Provides safety response to health authority assessor questions after filing and response to Health Authority inquiries on clinical studies, when necessary.
- Performs medical assessment of client individual case safety reports (ICSRs) including causality assessment, determination of expectedness, identification of events of interest, sentinel events and additional follow up for pre?and post marketed products as appropriate. Performs analysis of similar events for SUSARS.
- Authors relevant sections of the client’s DSUR/PSUR and conclusions of the product safety profile. Contribute safety sections and risk/benefit assessments. Reviews to ensure regulatory reports accurately reflect proper interpretation of findings. Assists in the preparation of safety sections and review of regulatory documents.
- Contributes to the mentoring of new colleagues. Develops and maintains comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the assigned product portfolio and current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions.
Qualifications:
Education and Experience
- M.D. or equivalent (D.O., M.B.B.S, etc.)
- Board certification preferred, however a variety of clinical experiences are well?suited for this
position
- >5 years of experience in risk management and pharmacovigilance (safety signal detection, data
mining techniques, pharmacovigilance databases, etc)
- Track record of successful management of product safety matters preferred
- Experience in the clinical and drug development process in a pharmaceutical/biotechnology
company and preparation risk management plans, aggregate reports and company core safety
information highly desirable
Essential Skills and Abilities
- Advanced analytical skills
- Basic leadership and decision?making skills
- Advanced communication skills
- Sound medical judgment
- Basic clinical and/or drug development expertise
- Good organizational and prioritization skills
- Excellent interpersonal skills (i.e. team player)
- Working knowledge of MedDRA
- Basic statistics and pharmacoepidemiology
- Ability to work with limited supervision
- Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds
- Flexibility and ability to adapt and learn quickly
- Ability to work under tight deadlines
Please forward all resumes to
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
|
