Associate Principal Scientist, Drug Safety

Job Description

The position

• Supports the Global Medical Safety (GMS) 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 the Signal Management Team (SMT) 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.

• Safety Science expert with primary ownership of designated products and/or medical devices. As an Associate Principal Scientist, overall independence, know-how for safety surveillance/ pharmacovigilance and epidemiological 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

Responsibilities

• Accountable for

  • maintaining product specific documents including but not limited to Vcards, 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.

• Contributes, if agreed to:

  • The Risk Management Safety Team (RMST) and supports the RMST lead by expert evaluation of literature and other aggregates data, signal validation and evaluation, Health Authority Response to Questions (RTQ) documents.

  • The creation of Aggregate Safety Reports (ASR) and Risk Management Plans (RMPs).

  • Health Hazard Evaluations (HHE) and Medical Assessment Memos (MAMs).

  • Company Core Data Sheet (CCDS)/Company Core Safety Information (CCSI) and key local labels (e.g., Summary of Product Characteristic [SPC], United States Prescribing Information [USPI], Patient Information Leaflet [PIL]).

  • Safety related activities of clinical studies (protocol, Investigator’s Brochure [IB] including Reference Safety Information [RSI], Informed Consent Form [ICF], and Clinical Evaluation Report [CSR]) as agreed with the DSL.

  • The development and/or implementation of Additional Risk Minimisation Measures (ARMMs).

  • Timely response to internal and external (other than Health Authority) requests e.g., legal, Regulatory Development Review Committee (RDRC), medical information, business partners, affiliates).

  • Technical Review Committee (TRC) and RDRC activities.

  • The onboarding curriculum and/or materials for new staff.

  • IT system selection, user requirements testing and providing user support, when requested

• 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 postmarketed 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 a timely response to requests posed by internal stakeholders.

• Active participation and contribution to product RMST

• Authoring, in collaboration with the GMS  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 GMS team and other stakeholders including regulatory, clinical development and epidemiology, and with strategic guidance from the TA lead, the authors of the safety science 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 GMS and the appropriate functional areas, and with strategic guidance from the TA head, reviews, provide 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 Safety Science Physician 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 Safety Science 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).

Required Education, Experience, and Skills

• 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

• 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 are 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.

• A minimum of 3 to 5 years of relevant experience in pharmacovigilance, drug safety, or related regulatory functions within the pharmaceutical, biotechnology, or medical device industries, or at health authorities.

• Practical experience in safety surveillance activities, including review of individual and aggregate safety data, signal management support, and preparation or contribution to regulatory safety documents (e.g., PSURs, DSURs, RMPs, labeling updates).

• Exposure to or direct involvement in clinical development activities, such as the review of clinical study protocols, Investigator’s Brochures, or safety sections of clinical development plans.

• Demonstrated ability to perform data retrieval, preparation, and preliminary analysis from pharmacovigilance and clinical databases, with sound interpretation to support safety evaluations.

• Familiarity with global pharmacovigilance and clinical safety regulations and risk management frameworks (e.g., ICH E2E, GVP modules, FDA, EMA)

• Experience with dermatological products (e.g., topical therapies, biologics, dermatology-focused medical devices) is considered a strong asset.

• An advanced degree in life sciences is required (e.g., PharmD, MD, PhD, or Master’s degree in Pharmacy, Medicine, Biomedical Sciences, Epidemiology, or a related discipline).

• Additional training or certification in pharmacovigilance, pharmacoepidemiology, or regulatory science is considered advantageous.

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:

Regular

Relocation:

No 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:

1

Requisition ID: R533751