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Offre: associate director, signal

Job description:

job details

   . 26. septembre 2021
   . basel, bâle-ville
   . life sciences
type d'emploi
   . contract
   . 16521
   . lucie nasshan, bâle professionals health care & life sciences
   . 058 201 55 50
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description du poste

Randstad 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.  


Job Category: Legal [ View All Legal Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: autre
Company Type Employer
Post Date: 09/25/2021 / Viewed 4 times
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