Drug Safety Specialist
2 meses atrás
Job Description
Please apply with your CV in English.**Applicants should be fluent in Spanish and Portuguese**
Responsibilities- Responsible for day-to-day adverse events case management including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
- Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and translation to English and forwarding of information to the Data Management Center. He/she also performing ICSR acknowledgments and reconciliation activities.
- Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
- Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations
- Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable
- Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
- Participates in and supports audits of contractual partners/vendors as necessary. May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
- Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Supports training of the local company staff, distributors, vendors, business partners including training documentation.
- May be assigned responsible for ensuring PV language is included in local agreements and ensuring maintenance of BDLM with respect to local and regional contracts.
- May be assigned responsibility for ensuring appropriate implementation and oversight of local Risk Minimization Measures and ARMMs
- Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight
He/she should have a minimum of 1 year of industry experience in in pharmacovigilance and/or regulatory affairs. He/she must have a general knowledge of PV regulations within his/her assigned country and be an expert in PV processes/activities. The Sr. Specialist is expected to have good communication and time management skills.
Education / CertificatesThe incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language.
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.
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:
RegularRelocation:
No relocationVISA 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:
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