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Sr Director, Pharmacovigilance Qa
Company | Insmed Incorporated |
Address | , Bridgewater, 08807 |
Employment type | |
Salary | $200,000 - $280,000 a year |
Expires | 2023-10-14 |
Posted at | 8 months ago |
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:Named Science’s Top Employer in 2021 and 2022
A Certified Great Place to Work
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Supports strategic direction with cross functional working groups to identify and mitigate GVP quality andcompliance issues/risks.
- Conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE’s/CAPAs.
- Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME) and act as company’s representative during regulatory agency inspections and vendor audits.
- CQA representative for review of PV SOPs/WIs, PSMF, SDEA’s, JOGs and other PV related documents.
- Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources.
- Supports the evaluation and acceptability of Pharmacovigilance vendors for potential use and provides direction, guidance and strategicconsultation for the company.
- Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities are conducted, reports written according to SOPs and that QEs/CAPAs are written, reviewed and followed up.
- Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).
- Structure and conduct internal Pharmacovigilance systems audits
- CQA representative on weekly/monthly pharmacovigilance meetings.
- Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice.
- Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
- Minimum BS degree in Chemistry or related life sciences discipline required with minimum 10-15 years of experience, 7 years of which are in Pharmacovigilance.
- Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
- Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required.
- Must successfully exhibit Insmed’s five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration.
- Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
- Ability to organize and conduct internal audits is necessary.
- Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs.
- Experience developing SOPs, reviewing internal pharmacovigilance, clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential.
- Stock options and RSU awards
- Professional Judgment Vacation Policy
- 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).
- Flexible approach to where and how we work
- Competitive compensation package including bonus.
- Employee stock purchase plan
- 401(k) plan with company match
ADDITIONAL U.S. BENEFITS:
- Company-provided short- and long-term disability plans
- Company-provided life insurance
- Employee Assistance Program (EAP)
- Mental Health on-line digital resource
- Medical, dental, and vision plans
- Flexible spending accounts for medical and dependent care
- On-site, no-cost fitness center at our U.S. headquarters
- Paid time off to volunteer
- Unique offerings of pet, legal, and supplemental life insurance
- Accident and Hospital Indemnity plans
- Supplemental AD&D
Additional Information:
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Please note that we review every submission, and we will keep all submissions on file for six months.
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