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9 days old

Medical Director of Safety Evaluation

Kelly Services
Raleigh, NC 27608
**Medical Director of Safety Evaluation**


Remote - Direct Hire with Sponsor


Kelly Science and Clinical is hiring a Medical Director of Safety Evaluation for one of our global research-driven pharmaceutical companies to grow with their team. This opportunity is a permanent position and offers a competitive salary, strong benefit options, as well as Annual Bonus + Long Term Incentives.


The Medical Director, Medical Safety Evaluation (MSE) is responsible for leading product level safety analysis and strategic medical safety management for global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Incumbent implements corporate policies to ensure the safety of the product in global development portfolio. The Medical Director is accountable for providing medical input to the assessment of the safety profile for each drug and for appropriate and timely regulatory reporting of safety issues.


**Responsibilities**


+ Leads overall medical safety evaluation for assigned global investigational products and clinical development program.

+ Participates in FDA or other health authority safety interactions/responses as the product safety lead.

+ Has full accountability for all aspects of the global drug safety function, including development/delivery of a quality Pharmacovigilance system for assigned products/activities. Is the primary safety representative between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, external experts, and CROs) on product safety related issues.

+ Leads safety signal detection activities and chairs global cross functional safety teams, with appropriate communication/escalation. Oversees/conducts signal tracking for products according to regulatory requirements and corporate business strategy.

+ Completes/reviews medical assessments of safety data [Periodic Safety Update Reports (PSURs, DSUR), safety sections for labels/IBs/regulatory submissions (e.g. IND/pre-NDA briefing books, safety queries), Safety Surveillance Plans, and CCDS] as appropriate and ensures the benefit/risk information is accurate.

+ Oversees development and preparation of Risk Management Plans (RMPs), safety portions (e.g., 2.7.4, ISS), and 120-day safety updates for regulatory approval filings.

+ Interacts extensively with regional and corporate departments to provide medical/drug safety strategic input to clinical research (scientific and operational), regulatory affairs, and global quality/manufacturing.

+ Works with cross-functional commercial teams to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities.

+ Oversees data collection, processing, assessment, and preparation of case reports, annual reports, and periodic reports to ensure the timely submission to international regulatory agencies as well as ensure quality medical assessment (e,g., case medical review oversight).

+ Provides overview of the safety aspects of the planning, execution, data collection and interpretation of clinical research. Performs medical review/approval of medically coded safety data, including adverse events, medical history and concomitant medications.

+ Accountable for the performance and results of the Drug Safety department and provides medical advice, training, and support. Implements department plans and priorities to address business and operational challenges.

+ Develops and implements strategies for Pharmacovigilance business plans in accordance with long-term company strategic plans. This includes active involvement and coordination with local and international Pharmacovigilance directors and physicians.

+ Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements. Improves organizational efficiency through outsourcing and other alliances.

+ Provides input to senior management, as requested, regarding safety aspects of brand strategy, key messages, data review, and future data needs.

+ Performs other departmental duties as assigned.


**Qualifications**


+ Medical Degree (MD or DO); current medical license preferred

+ Board Certification or equivalent in a medical specialty and significant clinical experience desired

+ Post-graduate training in clinical epidemiology and biostatistics is also desirable

+ Minimum of 8 years in the pharmaceutical industry with at least 5 years of experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions

+ Previous experience with leading strategic safety medical evaluation activities (e.g., Medical Director/Global Safety Officer level) at a product level is required

+ Experience writing/leading pharmaceutical regulatory or clinical research safety documents, including periodic safety reports, IB safety sections, and risk management plans required

+ Experience as lead safety physician for Phase I-III trials, especially with key safety activities (e.g. SMMP, CRO interaction, AOSE, IND update, AR, ISS) required

+ Experience with safety databases, including medical review of case reports (pre-marketed and post-marketed products) required

+ Contributor for PSUR, RMP, and DSUR documents

+ Experience as lead safety physician in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) preferred

+ Familiarity with US and International Safety reporting regulations and guidelines (in particular, ICH clinical safety guidelines)

+ Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization

+ Required to travel domestically and internationally typically up to 10%


\#ACRP


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-11 Expires: 2022-06-11

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Medical Director of Safety Evaluation

Kelly Services
Raleigh, NC 27608

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