Job Description
The Position
As a PV Case Exchange Sr. Specialist, you will play a crucial role in ensuring our organization’s adherence to industry regulation and standards by ensuring compliance of individual case safety reports to Regulatory Authorities and Business Partners.
Responsibilities:
Your primary responsibilities will include managing individual submissions, generating reports, and liaising with internal teams as well as regulatory authorities.
GPV Submissions mailbox monitoring for addressing submission related queries or requests received from Countries, Business Partners, or Regulatory Authorities.
OARS monitoring for identifying and resolving rejected electronic individual submissions.
Liaise with BT team or other relevant company stakeholders for ensuring reports are correctly generated and transmitted.
Monitoring all ICSR reports generated are appropriately submitted or actioned.
When needed, liaises with internal or external stakeholders for ensuring reception and maintenance of acknowledgments.
Manual transmission of individual case safety reports from OARS for a pre-determined list of destinations.
Participate in discussions with the Configurations team and BT team when setting up and maintaining reporting rules and reporting destinations in alignment with country regulations.
Support pre-determined countries when requiring fill up submission local forms.
Liaise with Regulatory Operations team for ensuring submission of Clinical trial reports to USFDA via eCTD are conducted.
Ensures to receive and maintain acknowledgment files when submissions via eCTD are conducted.
Manual identification, scheduling, and transmission of non-valid reports when needed.
Whenever required, provide input to investigations opened by the Quality team for addressing late ICSR cases to third parties or regulatory authorities.
Supports documentation of Quality Issues. Provide supports during audits and inspections when pertaining to ICSR submission.
Prepare monthly metrics to be shared and discussed with Case Exchange Lead.
Provide support for updating and maintaining procedures related to Submissions processes.
In addition to the responsibilities outlined above, the incumbent may be required to undertake additional ad hoc tasks or projects as necessary to support the department’s goals and requirements.
Required Education, Experience and Skills:
Graduate
ICSR Submissions experience (3-5 years of experience). This experience should include familiarity with relevant laws and regulations applicable to the industry.
Experience in engaging with stakeholders.
Proficiency with Global Safety Databases (ARGUS preferably)
Proficiency with Microsoft software’s (e.g., Word, Excel, power Point)
Strong organizational skills
Attention to detail and abilities to manage multiple deadlines.
Effective communication and team collaboration are essential, as the role will interact with various departments and external regulatory bodies.
Analytical skills, Problem-Solving Skills, Team Collaboration, Technical Proficiency, Flexibility and Adaptability, Integrity and Ethical Judgement, Time Management
Secondary Job Description
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.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, 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.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Relocation:
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: