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Medical Safety Manager

Skillman, NJ, USA | Leader of Pharmaceuticals, Medical Devices, and Consumer Goods Company

  • Industry:
    Consumer Products
  • Position Type:
  • Functions:
    Biotech/R&D/Science
  • Experience:
    5-7 years
Job Description:
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Johnson & Johnson Consumer Products Company is looking to hire a Medical Safety Manager located in Skillman, NJ.

The Medical Safety Manager will:

Supports the GMSO (Global MSO) or the SSO (Senior Safety Officer) and serves as GMSO designee providing medical safety oversight of co-allocated Consumer products or product families throughout the product life cycle in close alignment with GMSO. The Medical Safety Manager also ensures communication of potential and known risks, when appropriate, to direct management, the Consumer Qualified Person for Pharmacovigilance (QPPV), and personnel in all other relevant functional areas. He / she will ensure collaboration and coordination of activities with key functional partners such as R&D, Regulatory, Quality, Commercial, and Medical Affairs

Act as integration alliance manager under the GMSO leadership and in close relationship with cross-functional teams ensures early involvement, oversight plan and execution of safety integration process to enable proper and timely end to end safety integration of new companies/product acquisitions. When necessary, MSAD acts as onsite medical safety representative liaising with integrated company and MSO to ensure effective communication, proper oversight and support to guarantee successful launches in compliance with Safety Standards

Collaborate with, and at the direction of, the GMSO/SSO the Medical Safety Manager supports and/or contributes in the development of safety assessments and risk management

The Medical Safety Manager works in a cross-functional matrix environment and liaises with Medical Affairs (MA), Regulatory Affairs (RA), Research & Development (R&D), Toxicology, Quality Assurance (QA), and Legal to ensure accurate assessment of the safety information for assigned products

Act as safety-related point-of-contact and thought partner for all business partner activities and represents safety voice at product development meetings of co-allocated products ensuring early involvement and proper safety oversight along product lifecycle

Collaborates on due diligence activities and in collaboration with GMSO and interphase areas contribute on the development of integration plan and oversee its execution to enable end to end safety integration of new companies/product acquisitions

Provide onsite support of co-allocated product enabling effective communication and experience exchange between acquired companies and J&J

Participate in new product discussions from concept through development; share learnings and align with MSO

Collaborate in gathering relevant information, clarification on escalated quality issues with potential safety concern

Support safety integration plan is properly and timely executed

Build and sustain thought partnership and strategic collaboration with business and Enterprise stakeholders on topics that require integrated analysis; ensure appropriate development committee activities are implemented for development-stage products

Apply a systematic approach to identify and manage risks to maximize the benefit-risk or safety profile of the product, as appropriate for product type, throughout a product’s lifecycle. Review and manage the evolving safety profile of products during the product lifecycle; Safety Surveillance, Signal Detection, and Labeling; proactively ensure R&D safety insights and appropriate regulatory information and conclusions are applied to Quality and Commercial decisions

Under GMSO guidance, regularly review results of all available data from external and internal sources, spontaneous adverse event reports, and cumulative data from non-spontaneous (solicited) sources, provide medical clinical expertise for causality assessments and reporting of data and assessment results to internal (e.g., SMT) and external stakeholders (e.g., Health Authorities)

Reports to the Global Medical Safety Director SkinCare and Women Health within Safety Surveillance and Risk Management (SSRM) group

Qualifications

Qualifications:

Must have be an Medical Doctor (MD) or hold a Bachelor’s Degree in Health Sciences ( Biology, Pharmacy, Biomedicine, Nursing, Odontology etc)with 5+ years of relevant experience, preferably in the pharmaceutical industry(Medical, Regulatory or Safety Departments preferred) demonstrating experience in management of broad-ranging product safety activities with decision-making responsibilities is required

Knowledge of principles of drug, cosmetic and/or device safety, specifically ability to search, analyze and critically evaluate safety data from multiple sources preferred (clinical trials, environment, literature, etc), and clearly present in written format

Expertise in clinical trial monitoring, pharmacology, epidemiology, biostatistics and/or decision sciences is a plus

Prior team-managerial experience is preferred

The ability to work in a matrix environment is required

Proficiency in MedDRA (Hierarchy, SMQs) and advanced-level skills in MS Office (Outlook, Word, PowerPoint, and Excel) is required in addition to excellent verbal and written communication skills

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


 


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