Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Safety scientist

Company: United BioSource Corporation.
Location: Geneva, Switzerland
Reference: REQ20012800
Closing Date: 21 Feb 18
Type: Full Time
Salary (£): Competitive
Benefits:

Top Job

Job Summary:

Brief Description:This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, aggregate reports and risk management plans writing and project management; signal detection and assessment activities, health authorities responses writing; global and local literature review; training, mentoring and contributing to the development and maintenance of departmental standards ...

Requirements:

Brief Description:

This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, aggregate reports and risk management plans writing and project management; signal detection and assessment activities, health authorities responses writing; global and local literature review; training, mentoring and contributing to the development and maintenance of departmental standards (SOPs) and guidelines. 

Specific Job Duties:

  • Assist with the project plans as required
  • Participates in aggregate reports project management, including kick-off meeting preparation, team meetings leading, deliverable strategy preparation, timelines definition and coordination between cross functional participants (e.g. from drug safety, regulatory affairs, clinical, epidemiology, medical affairs, non-clinical).
  • Aggregate reports writing such as periodic benefit-risk evaluation reports, development safety update reports, six-monthly reports, periodic adverse drug experience reports, NDA annual reports
  • Preparation of answers to health authorities’ inquiries
  • Participates in safety signal detection activities involving regular review of individual case reports of interest, literature data and aggregate data.
  • Participates in safety signal evaluation based on data gathered from different sources
  • Preparation of addendum to clinical overviews to support label variations or marketing authorization renewal
  • Perform literature review for identification of case reports and other relevant safety information
  • Participates in risk management plans development and maintenance.
  • Collaborates with Management to update or design project process improvements
  • Liaise with both internal and external vendors
  • Review/Quality check (QC) of source documents and formatting according to clients style guides
  • Monitor compliance metrics and ensure appropriate documentation when deficient
  • Assist in evaluation and validation of systems to support safety
  • Preparation of training materials specific to safety, participate and/or lead training sessions
  • Other duties as assigned by management

Requirements:

  • Registered Nurse, Pharmacist, or Master’s degree in a Life Science-related field
  • Knowledge of ICH, EMA and FDA Regulations and Guidelines both clinical and post marketing pharmacovigilance and clinical safety
  • Prior experience in CRO/Pharma/Biotech safety department, minimum 3 years
  • Experience in medical writing preferable periodic aggregate reports and signal assessment reports
  • Proficient with computer programs (Safety database, Word, PowerPoint, Excel)
  • Good communication, interpersonal interaction, project management and organizational skills are essential
  • Fluent in English, additional language fluency a plus, but not required

About UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management.

Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.

By combining insight from data, understanding patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.

*LI-CD1-UBC

Apply for this job: Senior Safety scientist

Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.