Drug Safety & Pharmacovigilance Specialist - Onsite, Cambridge MA Primary Responsibilities: Partner with aggregate report leads, pharmacovigilance science leads and safety physicians to manage and support the authoring of aggregate safety reports, including PSURs, DSURs and line listings. Oversee scheduled and ad hoc line listings from generation through submission. Work with affiliate management and regulatory teams to develop and edit safety management plans and related documentation. Identify gaps in aggregate reporting processes and recommend or implement improvements. Collaborate with study teams, cross-functional partners, external business partners and vendors across assigned therapeutic areas. Support signal detection, signal evaluation and signal management activities. Contribute to data mining and safety signal reviews using internal and external data sources, including clinical and safety outputs, medical literature and health authority requests. Develop an understanding of the capabilities and limitations of various safety data sources. Assist with the evaluation of potential safety issues and quality risk assessments. Support safety committee activities, including preparing reports, meeting materials and minutes, tracking action items, and participating in discussions related to patient safety. Communicate safety information, context and urgency to relevant team members. Coordinate cross-functional meetings to support issue resolution and decision-making. Support safety risk management team preparation and documentation with guidance from senior team members and safety physicians. Provide training and support to new staff regarding department processes and therapeutic area knowledge.
Education:
A degree in a medical, healthcare or life sciences-related discipline is required. Examples may include nursing, pharmacy, physician assistant studies, medicine or a related field.
Qualifications:
Three to five years of experience in the pharmaceutical or biotechnology industry, with experience in drug safety or pharmacovigilance.
Experience supporting aggregate safety reporting, signal management, safety surveillance or risk management activities.
Knowledge of pharmacovigilance regulations and global safety reporting requirements.
Experience with safety databases such as Argus or Arisg.
Experience with signal detection or data analysis tools such as Empirica or Spotfire.
Experience developing or implementing dashboards and data displays for signaling, compliance, KPIs or quality metrics.
Understanding of the drug development process and pharmaceutical regulations.
Experience supporting process improvement initiatives and translating ideas into practical business solutions.
Ability to work independently in a cross-functional, matrixed environment. Strong planning, organizational, analytical, written and verbal communication skills. Experience working across international teams or geographic regions is preferred.
Clinical patient care experience is a plus.
Special Skills: Ability to represent the drug safety function in internal and external meetings.
Experience coordinating cross-functional briefings, technical meetings and project discussions.
Strong problem-solving, reasoning and decision-making skills. Ability to work diplomatically with stakeholders and help drive issues toward resolution.
Strong analytical and scientific writing skills. Ability to manage activities involving cross-functional teams, business partners and contract research organizations.
Job Complexity: This role supports aggregate report management and risk management activities throughout the product lifecycle. The position requires coordination across multiple functions, external partners and contract research organizations. The individual will be responsible for helping ensure the successful execution of activities related to drug safety and risk management. The individual is expected to work independently with support from management and senior colleagues.
Estimated Min Rate: $68.60 Estimated Max Rate: $98.00
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements.
Benefits include:- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)401K Retirement Savings PlanDirect Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note:
Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. 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. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-noticeStay Safe During Your Job Search Fraudulent recruiting communications have become increasingly common. Emails from Yoh recruiters will only come from an @yoh.com email address. Yoh will never ask candidates to pay fees, purchase equipment, send gift cards, or transfer funds as part of the recruiting or hiring process. If you receive a communication that appears suspicious or requests payment, contact Yoh directly before responding or sharing personal information.
Reference: BH-400709
