Offre: associate director, signal management:Randstad.chJob description:
job detailspublié . 26. septembre 2021 lieu . basel, bâle-ville secteur . life sciences type d'emploi . contract référence . 16521 contact . lucie nasshan, bâle professionals health care & life sciences téléphone . 058 201 55 50 appliquer > description du posteRandstad Professionals is looking for an Associate Director, Signal Management for a major client. This situation will be based in Basel . Startdate: ASAP (up to 3 month notice period possible) Contract: 12 months This situation will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities: . Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: . Lead all signal management activities for assigned product(s) . Support implantation of signal detection strategy approved by VP of Pharmacovigilance . Review adverse event data, literature and other safety-related data for the purpose of signal detection . Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans . Partner with the Director, Pharmacovigilance ? Signal Management to oversee digital signal detection and management tool. . Serve as an administrator of the tool . Propose and implement signal detection methods in the tool . Train, mentor and assist CSRM staff in using the tool. . Oversee signal tracking and signal notifications to external stakeholders . Generate periodic signal management compliance metrics . Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues . Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues . Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management. . Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables . Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission . Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents . Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons . Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues . Draft regulatory response documents such as PRAC assessment reports . Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements: . Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background . Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years? experience in Pharmacovigilance . Excellent written and verbal communication skills with the ability to interpret and present safety data . Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process . Knowledge of drug safety/pharmacovigilance practices and tools . Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision . Background in vaccines is a plus . Demonstrated ability to develop, execute and follow-through complex projects to completion . Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view . Independently motivated, detail oriented and strong problem-solving ability . Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities . Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position. Skills:
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