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$200k–$300k/yr
Full-time
postgraduate degree
Annual Bonus, Annual Equity Awards, Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off
Posted 39d ago
~40 hrs/week
Responsibilities
The Associate Medical Director provides medical safety expertise and pharmacovigilance for assigned products throughout their life cycle. This includes monitoring benefit-risk profiles, analyzing clinical safety signals, and contributing to periodic safety reports.
Requirements
Candidates must hold an MD, DO, or equivalent medical degree with typically 3 years of experience in safety or pharmacovigilance. Proficiency in regulatory requirements and the ability to interpret complex safety data are essential.
Full job description
Job Description
General Summary:
The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). This role will optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe, through the effective and timely completion of Safety activities through the product life cycle.
Key Duties and Responsibilities:
Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development)
Responsible for the safety assessment activities of assigned products under the supervision of a GPS Disease-area Safety Head
Monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
Leads the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
Identifies, prioritizes and analyzes clinical safety signals, in accordance with GPS procedures
Performs ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
Represents the department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing guidance regarding safety matters and issues
Conducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed
Participates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
Participates in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports
Contributes to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
Review and provides medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter
Assists in departmental development activities including SOP and Work Instructions development
Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
Provides support in Partner /Affiliate agreements and interactions, as needed
Other activities as needed or as requested by GPS management
Knowledge and Skills:
Broad and extensive knowledge of medicine, pharmacovigilance and relevant regulations
Extensive evidence of effective delivery of high quality safety relevant documents.
Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information
Communicates complex issues in an understandable, effective and relevant manner.
Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition
Strategic focus regarding activities, with proactive planning and prioritization skills.
Takes ownership of appropriate issues and appropriately delegates
Technical expertise in pharmacovigilance and clinical safety
Excellent analytical and problem solving skills, with sound autonomy and applied judgment
Appropriate experience with Regulatory Agency and key stakeholder interactions
Experience with ICSR case review and Aggregate Safety analysis and reports
Education and Experience:
MD, DO or equivalent ex-US medical degree
Typically requires 3 years of experience with relevant experience in Safety/Pharmacovigilance, or the equivalent combination of education and experience
Pay Range:
$200,000 - $300,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
Related keywords
PharmacovigilancePatient SafetyMedical DirectorDSURPSURPADERICSRClinical Study ReportsBiotechnologyRegulatory AgenciesSignal AnalysisToxicologyNon-Clinical StudiesIBICFIDMC Charter
Together we deliver connected solutions to conquer tax complexity.
Industry
Software Development
Company size
1,001-5,000 employees
Headquarters
King of Prussia, PA
LinkedIn followers
68,717
Total funding
$345M
The rapid changes taking place in today’s global business, technology, and regulatory environments are having a compounding effect on the complexity of indirect tax management and putting more pressure on the corporate tax function than ever before. This complexity demands intelligent solutions that enable businesses to satisfy tax obligations and support growth opportunities.
The Trusted Leader in Tax Technology
We're Vertex (VERX). A pioneer in tax automation for more than 40 years. We proudly serve over 4,000 customers worldwide with distinction and provide comprehensive tax solutions that enable global businesses to transact, comply and grow with confidence.
Our software, content and services address the increasing complexities of global commerce and compliance by reducing friction, enhancing transparency and enabling greater confidence in meeting indirect tax obligations. As a result, our software is ubiquitous within our customers’ business systems, touching nearly every line item of every transaction that an enterprise can conduct. Our software is fueled by over 300 million data-driven effective tax rules and supports indirect tax compliance in more than 19,000 jurisdictions worldwide.
We partner with the world’s most respected companies and harness their strengths to deliver the best tax technology solution to businesses across the globe. We integrate with key technology partners that span ERP, CRM, procurement, billing, POS and e-commerce platforms. We also work closely with over 50 tax, accounting and consulting firms to provide the integrated tax technology solutions.
Our culture is the foundation of everything we do, guided by a common purpose to build trusted relationships at work, in business and in our communities. We strive to be a values-driven employer of choice who attracts, retains and inspires talented professionals to achieve their full potential. We employ over 1,100 full-time professionals today in the US, Europe and Brazil.
Offices: 2301 Renaissance Blvd, King of Prussia, PA 19406, US · 40 Shuman Blvd., Suite 218, Naperville, IL 60540, US · 1 Furzeground Way, Stockley Park, Stockley Park, Uxbridge UB11 1EZ, GB · 101 Arthur Andersen Parkway, Suite 300, Sarasota, FL 34232, US · Gustav Mahlerplein, Amsterdam, North Holland 1082, NL
taxtransaction taxindirect taxtax compliancesoftwareVATvalue added taxsales and usemanaged servicesreturns outsourcing
How much do Security & Safety jobs in Massachusetts pay?
Based on 1914 listings with disclosed salaries, most security & safety jobs in Massachusetts pay between $80k–$203k per year. Individual offers vary with seniority, company size, and specialization.
How many Security & Safety jobs are open in Massachusetts right now?
There are currently 4,416 open security & safety positions in Massachusetts listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Security & Safety roles in Massachusetts?
Companies currently hiring include RTX, Allied Universal, MassDEP, mouhamedzz, General Dynamics Mission Systems, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Security & Safety jobs in Massachusetts?
Yes — 715 of the 4416 open security & safety positions offer remote or hybrid work (230 remote, 485 hybrid).
How do I apply for Security & Safety jobs in Massachusetts?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.