(Associate) Manager Pharmacovigilance (all genders)
(Associate) Manager Pharmacovigilance (all genders)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
People. Passion. Possibilities. Three words that make a world of difference.
More than a job. Its a chance to make a real difference.
Welcome to AbbVie! As part of an international company with 50000 employees worldwide and around 3000 employees in Germany you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care Do you want to contribute to improving patients quality of life through your expertise In a challenging work environment that offers opportunities of developing and increasing your own skills Youve come to the right place!
As part of the Regional Safety Operations team at the Wiesbaden site you will be working with talented people and experienced management experts to maintain a highfunctioning PV system enhance our drug safety processes and protect patient wellbeing.
Together we break through as (Associate) Pharmacovigilance Manager
As an (Associate) Pharmacovigilance Manager you will support the Pharmacovigilance Lead (PV Lead) and the Affiliate Safety Representative (ASR) in all aspects of role and responsibilities ensuring that the local PV activities and requirements are in line with AbbVie Processes and procedures the Code of Business Conduct and the local laws.
Make your mark:
Your main responsibilities will be as follows:
- Safety Science:
- Support ASR in setting a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product / indication launch at the affiliate
- Build strong partnerships and work collaboratively with stakeholders and other functions across the business such as Regulatory Affairs Medical Affairs Brand Teams as applicable
- Maintain awareness on safetyrelated product enquiries/issues received from external stakeholders/vendors working with Medical Affairs Regulatory Affairs Area Product Leads and the PSEQ Product Safety Team as required.
- Involve internal local stakeholders with respect to the results of product safety monitoring effectively communicating relevant safety information that can impact business strategies
- Perform surveillance of Local Safety Information and escalate to Affiliate Medical Director and PSEQ for evaluation on a timely manner
- PV System Oversight:
- Collaborate with Pharmacovigilance and Patient Safety Epidemiology R&D Quality Assurance (PSEQ) regional teams and local PV teams to support the PV Lead and the ASR in ensuring oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations internal company timelines/standards.
- PV Training:
- Support the ASR and PSEQ Regional PV Teams in ensuring overall training compliance with corporate procedures and local PV requirements coordinating the maintenance of the local PV Training matrix and the development and subsequent rollout of additional PV Training as required (e.g. Risk Minimization Trainings)
- Perform training activities in the context of AbbVie Employee onboarding ensuring proper documentation
- Medical Research Support:
- Ensure that PV requirements are implemented in all applicable observational studies/PostMarketing Observational Studies (PMOS) and InvestigatorInitiated Studies (IIS).
- Quality Management:
- Support ASR and PSEQ Regional teams to ensure quality systems are in place and in line with corporate procedures and local requirements:
- Collaborate on the creation and maintenance of local PV guidelines
- CAPA Management
- Support the ASR in ensuring that a riskbased Business Continuity plan is in place allowing for continuation of critical business process for PV; coordinate its testing
- Audits and Inspection Management:
- Support ASR and PSEQ Regional Teams in managing internal PV audits of affiliate service providers/third parties and Regulatory Authority PV Inspections (including corresponding CAPA development and actiontracking to completion in a timely manner)
- Additional Responsibilities:
- Coordination of the local PV Mailbox
- Support in PV Review and Approval of promotional and nonpromotional Materials
Qualifications :
SKILLS
- Quality mindset
- Global view/mindset
- Good communicator/influential
- Excellent organizational and analytical skills with attention to detail
- Ability to identify manage and escalate issues in a timely manner
- Process and operational excellence
EDUCATION/KNOWLEDGE
- Academic and/or professional scientific background
- Advanced lifescience degree (e.g. M.S. M.B.A. PharmD.) preferred
- Read write and speak fluent English and German
EXPERIENCE
- Minimum 3 years of PV experience
- Broad PV systems knowledge Experience in PV case processing understanding of medical terms and medical causal relationships ideally also experience in Signal Management RMP DSUR PSUR compilation and interpretation
- Thorough knowledge of local/regional/area legislation and guidance (clinical trial pre and postmarketing)
- Ideally experience in Safety Science Strategies and Execution
- Change management
- Knowledge of root cause analysis principles
What we offer you:
- a diverse work environment where you can have a real impact
- an open corporate culture
- an attractive salary
- an intensive onboarding process with a mentor at your side
- flexible work models for a healthy worklife balance
- a corporate health management that offers comprehensive health and exercise programs
- company social benefits
- a wide range of career opportunities in an international organization
- toptier attractive development opportunities
- a strong international network
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
