Drug Safety Scientist

hace 2 meses

Bogota, Colombia Merck A tiempo completo

**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.
- 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.

**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.
- Collaborating with GPSS and the appropriate functional areas, and with strategic guidance from the TA head, revi

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