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Job Details

Global Medical Safety Manager - The Netherlands (12month contract)

Company: Planet Pharma Staffing Limited
Location:
Reference: GSM/NDL-00146
Closing Date: 25 Dec 16
Type: Contract
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

Excellent opportunity for a Global Safety Manager to join a world leading Pharmaceuticals company based in The Netherlands.

Requirements:

RESPONSIBILITIES

Medical Safety Activities Product Responsible person (PRP):

- Responsible and accountable for the coordination and medical-scientific monitoring and assessment of the safety profile of one or more specific products assigned to the Global TA.

- As this position is the most junior level PRP, it is expected that the Group Lead or (Medical) Director will closely supervise the activities of this position.  Assigned products will include marketed products without significant ongoing regulatory interactions or interactions with multiple license partners; typical, straightforward global development products.

- Responsible and accountable for the coordination and medical-scientific monitoring and assessment

- As this position is the most junior level PRP, it is expected that the Group Lead or (Medical) Director will closely supervise the activities of this position.  Assigned products will include marketed products without significant ongoing regulatory interactions or interactions with multiple license partners; typical, straightforward global development products.

- Leads GPV Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and participates in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of products for the assigned Global TA and contributing to an optimal benefit-risk profile.

- Under the close supervision of the Group Lead or (Medical) Director, responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator’s Brochure and local product labeling.   

- Under the close supervision of the Group Lead or (Medical) Director, responsible and accountable for the design of safety surveillance strategies, management of safety signals for company drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Global Safety Science.

 

Strategy Development and Execution

- Supports the Global TA Group Lead, and, as appropriate (Medical) Director in the implementation of process improvements tools, systems and procedures within GMS to ensure efficiency and consistency in safety surveillance in the assigned Global TA and other Global TAs and Regional Teams within GMS, as well as on GPV level.

- Supports the Global TA Group Lead, and, as appropriate (Medical) Director in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to the respective Global TA, ensuring feasibility and global alignment in collaboration with the GMS Leadership team.

 

QUALIFICATIONS

·         Bachelor's degree in a scientific, health-related field.

·         Minimum of at least 5 years of experience in the pharmaceutical industry and/or a relevant health science setting (such as academia). Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus.

- Basic understanding of safety regulations for both marketed and investigational products, regional and global authority requirements, including ICH, and other applicable requirements.

-  Demonstrated leadership capabilities, including the ability to work within a matrix environment.

- Sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stakeholders.

- Specific working knowledge of medical safety functions, including risk, signal management and periodic reports, prior experience not required.

- Written fluency in English.

- Strong interpersonal skills required with a demonstrated ability to handle conflict situations, generate solutions to problems.

- Ability to deliver under pressure with limited resources.

 

CONTACT:

Sam Chapple at Planet Pharma is handling the position. Please call his direct line or email any questions concerning the position.

DD: +44 203 868 8607

Email: schapple@planet-pharma.co.uk

 

 

 

 

Apply for this job: Global Medical Safety Manager - The Netherlands (12month contract)

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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