Associate Director, Clinical Program Quality

job summary:
The Associate Director/Director of Signal Management serves as a global subject matter expert responsible for ensuring that signal detection and evaluation processes meet the highest industry standards. This role is essential for maintaining strict compliance with EU regulations and global pharmacovigilance expectations through the development of robust, cross-functional processes alongside Regulatory Affairs and Data Science teams. The successful candidate will represent the department during health authority inspections and audits, ensuring that patient safety and regulatory integrity remain at the forefront of the organization's mission.

location: Cambridge, Massachusetts
job type: Contract
salary: $100.00 - 113.93 per hour
work hours: 9 to 5
education: Masters

responsibilities:

• Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders.
• Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.
• Ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company's products.
• Ensure patient safety for company's products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe.
• Represent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report back relevant information regarding status, issues, and/or challenges.
• Strategize and align with the GSLs in developing data analysis strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies.
• Create visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters.
• Provide input to safety documents and reports to submitted to regulatory authorities.
• Supports inspections and audits related to Signal Management and associated commitments.
• Leads interactions with other PSPV functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose.
• Leads interactions with other relevant functional areas both within and outside of PSPV to ensure standards are maintained.
• Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.
• Leads training for PSPV and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained.
• Leads interactions and oversight of signal management activities conducted by any vendor.
• Leads interactions with other relevant functional areas both within and outside of PSPV to ensure standards are maintained.
• Designs and delivers relevant training as appropriate.
• Provides mentorship and guidance for junior/new pharmacovigilance scientists, interns/fellows and others as appropriate.
• Conduct project activities for designated processes.
• Lead and conduct state-of-the-art research in the area of AI/ML.
• Lead current projects and innovative opportunities by providing subject matter expertise and technical support.
• Design, drive and promote novel advanced analytical tools building the next generation of safety capabilities by delivering value adding benefit/risk information.
• Actively lead teams and guide team members to develop and integrate innovative solutions for AI/ML applications and other digital strategies.
• Generate the data including descriptive statistics, trend analysis, outliers and correlations, and provide a preliminary assessment of relevant data, as well as reviews of prior data and relevant comparisons.
• Perform program/project management and business development.

qualifications:
Required:

• Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy, or nursing degree) with at least 5 years of experience in clinical, pharmacological, or related fields of expertise
• Excellent communication and interpersonal skills and experience in mentoring others
• Ability to review, analyse, interpret, and present complex data to a high standard.
• Global player in a global PV organization
• Excellent strategic decision-making and analytical skills - Strong leadership skills with excellent track record
• Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
• Strong verbal, writing and organizational skills, including a good command of English.
• Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• In depth knowledge of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis
• Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
• Experience with the preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
• Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
• Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels

skills: Pharmacovigilance, Periodic Adverse Drug Experience Report (PADER), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), FDA Submissions


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.