Drug Safety Scientist - Bogota, Colombia - Organon

Descripción

Job Description

The Position

• Supports the Global Pharmacovigilance and Safety Science (GPSS) team in the safety surveillance (e.g., signaling) and risk management (routine – as well as additional risk minimization measures, Risk Management Planning) of assigned, more complex established brands products and/or key new asset products (devices and/or medicinal products).
• Authoring (drafts) of regulatory documents and aggregate safety reports with cross-functional collaboration, including but not limited to Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Renewal documents.
• In addition, with guidance from Global Medical Safety (GMS) team, assists with the safety surveillance review /signaling activities of individual adverse experience (AE) reports including the individual Device Adverse Event (DAE) reports, aggregate individual case safety report (ICSR) reviews, and with the development and evaluation of risk management plans (RMPs) and the various risk management files related to devices.
• GMS expert with primary ownership of designated products and/or medical devices. As an Associate Principal Scientist, overall independence, knowhow for safety surveillance/ pharmacovigilance and epidemiologic principles to complete signal detection, evaluation, and risk management process for assigned products throughout their life cycle and resourcefulness in all tasks and processes related to the products' safety surveillance and risk management are expected.

Organizational Relationships

• Under the general direction of the Drug Safety Scientists Lead

Primary Responsibilities

• Accountable for
  • Maintaining product specific documents including but not limited to V-cards, product-specific MedDRA coding instructions, and follow-up (FU) questionnaires.
  • Safety data retrieval, analysis and cross functional communication.
• Responsible
  • for Signal management timelines and quality of activities (including documentation).
  • to take over activities of new medicinal product/device integration if applicable.

Tasks

• Leads the quality assurance of prepared responses to inquiries from health professionals, regulatory agencies and other stakeholders regarding adverse experiences reported products in preclinical, clinical, and post-marketed phases of development.
• Periodic review of AE reports at an individual and aggregate level, including presentation of safety data to the RMST.
• Continuously assess the benefit-risk profile at every stage of the medicine's development and for the entire time the medicine is on the market.
• In collaboration with DSL, for timely response to requests posed by internal stakeholders.
• Active participation and contribution to product RMST.
• Authoring, in collaboration with the GPSS team, and with strategic guidance from the Therapeutic Area (TA) lead, of agency responses and regulatory documents, including but not limited to PSURs, DSURs, RMPs, Investigational New Drug (IND) and New Drug Application (NDA) Annual Safety Reports, Periodic Adverse Experience Reports (PAERs), Clinical Evaluation Report (CER), Product Renewal's documentation and Clinical Overviews, as well as contributes to authoring and updating the Company product's labeling. In addition, conducts literature reviews, identifies background population rates and summarizes and interprets relevant findings to support regulatory responses, health authority commitments, and PSURs.
• Supports the submission process for regulatory documents and publications.
• With the GPSS team and other stakeholders including regulatory, clinical development and epidemiology, and with strategic guidance from the TA lead, authors the GMS contribution to global regulatory submission documents required for filling applications for new products, formulations, or indications (briefing books, Benefit-risk Assessment [BRA]), and all associated documentation (e.g., informed consent, investigator brochure).
• Collaborating with GPSS and the appropriate functional areas, and with strategic guidance from the TA head, reviews, provides safety input into Clinical Development planning activities and clinical documents (e.g., investigator brochures, clinical study protocols, informed consents, clinical study reports, etc.) for their assigned products, and ensures that risk-reduction strategies are implemented appropriately.
• As required, cooperates and participates in Label Evaluation and Development Team (LEAD)/ Label Approval Strategy Team (LAST) meetings with the Drug Safety Lead and produces regulatory supporting documentation for labelling updates.
• In partnership with the DSL responds to manufacturing or device-related queries requiring safety health hazard evaluation writing and safety position communication.
• May coach and train more junior GMS personnel in signal evaluation methodology, risk management and preparation of safety reports and other documents.
• May lead process initiatives and innovation in PV methodologies as Subject Matter Expert (SME) (involvement & ownership).

Competencies

• Excellent leadership in matrix team setting
• Presentation skills
• Problem solving ability
• Analytical mind
• Can manage peaks in workload and time pressure
• Proactive and results oriented
• Team player
• High quality output mindset

Qualifications

• Excellent writing and verbal communication skills.
• Collaborative working skills in the cross-functional matrix team environment.
• Independent programmatic skills e.g., Microsoft program package (Word, Excel, and PowerPoint) or other pharmacovigilance computer software programs to assist data analysis is required with data management.
• Skillful in data retrieval, data preparation, preliminary analysis, and quality assurance.
• Quality assurance and compliance experience highly desirable.
• Management quality assurance and compliance experience is required.
• Medical Doctor with 3 or more years of clinical experience (additional pharma experience / PV experience a plus but not required)
• Bachelor's, or above, degree in a Biomedical or Health Care-related field (e.g., nursing, pharmacy, etc.) is required and >5 years of professional experience that includes both clinical and pharmaceutical experience.
  • The pharmaceutical experience should include a minimum of 3 years of relevant Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents.

Education

• Doctorate level or
• Bachelor's degree in a related field or Master of Science degree in life sciences

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:

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: