Blink - The Employee AppBoston, 10 mi from Waltham (MA)
Luke’s, Elara Caring and Dominos.
Requirements
Senior Content Marketing Manager
This is the kind of marketing opportunity B2B content marketers dream of. Real product market fit, an ocean of happy customers with inspiring, impactful stories to tell...
Abcam PlcWaltham (MA)
Job Description
Abcam’s VP Marketing is responsible for building and executing our global marketing strategy to grow our brand and drive exceptional commercial results for Abcam. You’ll have strong marketing and business development expertise...
NucleraBillerica, 10 mi from Waltham (MA)
scientific content for marketing materials and sales tools. If you possess a passion for forging strategic alliances, alongside a knack for crafting engaging content, this role offers an exciting opportunity for growth and impact.
About the role
Strategic...
Booz Allen HamiltonLexington
Cloud Application Migration Project Manager. As an Application Migration Program Manager, you know how to take advantage of cloud. Experience with project management tools, including Jira, Trello, or Asana. Knowledge of project management methodologies, including Agile, Waterfall, and DevOps.
...
OutlierBoston
In this role, you will become an AI Content Editor, assessing the quality of AI-generated writing, reviewing the work of fellow writers, and crafting original responses to prompts in order to teach the model what truly excellent writing looks like.
...
OutlierBoston
In this role, you will become an AI Content Writer, assessing the quality of AI-generated writing, reviewing the work of fellow writers, and crafting original responses to prompts in order to teach the model what truly excellent writing looks like.
Highlights:</strong></p><ul><l...
OutlierBoston
In this role, you will become an AI Content Editor, assessing the quality of AI-generated writing, reviewing the work of fellow writers, and crafting original responses to prompts in order to teach the model what truly excellent writing looks like.
...
Agile Talent ConsultingBoston, 10 mi from Waltham (MA)
we emphasize actionable data and tangible results.
THE OPPORTUNITY
TribalVision is seeking a Content Marketing Manager to frame the agencys content marketing offering and provide strategic and innovative solutions for unique client challenges...
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Medical Director, Pharmacovigilance
Waltham (MA) | www.resume-library.com |
Job Description
We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.
The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
Responsible for keeping upper management informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Safety lead for a specific compound / product.
The successful candidate will demonstrate the flexibility and capability to function at a high level and will be comfortable working in an entrepreneurial environment to advance the safety understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management.
What You’ll Do:
Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned product.
Provides pharmacovigilance expertise to oversee and lead decision making based on risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation
Perform medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines
Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility
Assist with development of the protocol, Investigative Drug Brochure (IDB), Informed Consent Forms and/or Case Report Forms (CRFs)
Perform review and clarification of trial-related Adverse Events (AEs), coding and consistency in assessment
Perform medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative
Attend Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested
Support inspections and audits, act as a subject matter expert for the assigned program (s)
Provide training on product and medical review to vendor/ team members as needed
Completes tasks on time or notifies appropriate person with an alternate plan.
Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
Attend/lead Safety committee meeting to support key decision-making, drive conclusions and develop next steps
Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments
Participate in development and maintenance of risk management plans and REMS as applicable.
Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports
Contribute to preparation of relevant regulatory documents and responses to regulatory agency, IRB, Site and Medical information queries
Provide consultation for medically related questions from participating vendors, affiliates, etc.
Use in-depth knowledge of Pharmacovigilance science and Regulatory Guidance to provide expertise and insight to cross-functional colleagues as appropriate
Develop/assist in creation of internal SOP and review vendor SOPs as needed.
Support in Inspections and Audits as needed
Other relevant duties as assigned
We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.
The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
Responsible for keeping upper management informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Safety lead for a specific compound / product.
The successful candidate will demonstrate the flexibility and capability to function at a high level and will be comfortable working in an entrepreneurial environment to advance the safety understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management.
What You’ll Do:
Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned product.
Provides pharmacovigilance expertise to oversee and lead decision making based on risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation
Perform medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines
Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility
Assist with development of the protocol, Investigative Drug Brochure (IDB), Informed Consent Forms and/or Case Report Forms (CRFs)
Perform review and clarification of trial-related Adverse Events (AEs), coding and consistency in assessment
Perform medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative
Attend Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested
Support inspections and audits, act as a subject matter expert for the assigned program (s)
Provide training on product and medical review to vendor/ team members as needed
Completes tasks on time or notifies appropriate person with an alternate plan.
Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
Attend/lead Safety committee meeting to support key decision-making, drive conclusions and develop next steps
Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments
Participate in development and maintenance of risk management plans and REMS as applicable.
Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports
Contribute to preparation of relevant regulatory documents and responses to regulatory agency, IRB, Site and Medical information queries
Provide consultation for medically related questions from participating vendors, affiliates, etc.
Use in-depth knowledge of Pharmacovigilance science and Regulatory Guidance to provide expertise and insight to cross-functional colleagues as appropriate
Develop/assist in creation of internal SOP and review vendor SOPs as needed.
Support in Inspections and Audits as needed
Other relevant duties as assigned
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