Organon & Co. Organon - Clinical Safety Risk Management Physician (Remote) in Jersey City, New Jersey
Under the general direction of the Clinical Safety and Risk Management Group Lead, the Safety Physician is an is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed medicinal products and medical devices. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars. The incumbent is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications.
The incumbent is a member of the Product Development Teams and chairs the Risk Management and Safety sub team for assigned products.
Partners with appropriate company departments and therapeutic area heads to ensure efforts are aligned to meet our global risk management strategies for assigned products.
Works with Safety Science Therapeutic Area Lead to plan direction for risk management functions of the department, helps develop processes for the function of the program, and implement specific programs to achieve identified goals.
The safety physician is accountable for the medical evaluation of safety signals and risks and the design of appropriate risk communication and risk management strategies in relevant regulatory documents (such as Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs, including Device Risk Management Plans), Clinical Overview, agency responses) and interactions. This includes health hazard evaluations for product complaints, manufacturing deviations and device malfunctions.
Position can be based remotely
Qualification, Skills & Experience
- MD or equivalent degree from an accredited medical school with 2 years of clinical experience
Skills & Experience:
Must have excellent communication, writing and analytic skills
Experience in Drug Safety, Pharmacovigilance and/or Risk Management Industry experience in both an Investigational and Post-Market capacity
Prior Clinical experience after completing education
Preferred Experience and Skills:
Board certification in designated medical field highly desirable
Training and/or experience in public health, epidemiology, and/or quantitative sciences
Experience with medical writing
Who we are …
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s
Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear: A better and healthier every day for every woman.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.
At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Organon & Co., Inc., Jersey City, NJ. USA, also known as Organon & Co., Inc., Jersey City, NJ. USA , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
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Number of Openings:
Requisition ID: R117544