Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Senior Pharmacovigilance Leader, Contract, Switzerland
Eingestellt von Michael Bailey Associates - UK Contracts
Gesuchte Skills: Client, Css
Projektbeschreibung
For our Life Science client in Basel, we are seeking for a Sr. Pharmacovigilance Leader (PVL)
Start Date: 02nd August 2016
End Date: 31st January 2017 + extensions
Location: Basel
Language: English
YOUR ROLE AS A SR. PHARMACOVIGILANCE LEADER:
- Acts as the primary contact point with PVE in HYD, CSS and co-ordinates product-specific activities.
- Performs medical review of individual SAEs from clinical trials with the support of the PVE as applicable and is responsible for preparation/submission investigator notifications
- Performs medical evaluation of quality defects.
- Acts as back-up for medical review and assessment and related activities for single cases (post-marketing and/or clinical trials), including requesting additional medically relevant information.
- Identifies safety signals based on the review of solicited or unsolicited single case reports, aggregate data and signal detection tools (ie EMPIRICA) and performs signal evaluation and monitoring.
- Prepares clinical expert statements related to signal evaluation (eg literature, clinical; non-clinical, epidemiology).
- Responsible for review of study protocols (including MRC or OPRC if applicable).
- Responsible for medical input to aggregate clinical safety regulatory reports (eg, PSUR, DSUR).
YOUR EXPERIENCE:
- MD
- At least 5-7 years of experience in Global Drug Safety (preferably Big Pharma)
- Broad experience in safety regulations and requirements; desirably knowledge of trials in oncology
- Good writing skills (aggregated safety reports etc.)
- Leadership (leading international cross functional teams); preferable candidates who worked as well already in other areas outside of Safety before (eg, Clinical, Medical affairs etc.)
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
Please note there is a job description available on request.
We hope that the role will be of interest to you and understand that further information may be required prior to an application to the end client, please feel free to email or call me at anytime with any questions you may have.
Looking forward to hear from you soon,
Kind regards,
Neha Sharma
Pharmaceutical & Life Sciences Business Developer
Recruiting Team MBA,
Michael Bailey Associates
Key words: Quality, Pharmacovigilance, safety management, life cycle management,EMPIRICA, PSUR, DSUR, MRC, MAP, OPCE, RAP, ICF, IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, Drug safety, epidemiology, Argus, regulatory, clinical trials, Basel
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start Date: 02nd August 2016
End Date: 31st January 2017 + extensions
Location: Basel
Language: English
YOUR ROLE AS A SR. PHARMACOVIGILANCE LEADER:
- Acts as the primary contact point with PVE in HYD, CSS and co-ordinates product-specific activities.
- Performs medical review of individual SAEs from clinical trials with the support of the PVE as applicable and is responsible for preparation/submission investigator notifications
- Performs medical evaluation of quality defects.
- Acts as back-up for medical review and assessment and related activities for single cases (post-marketing and/or clinical trials), including requesting additional medically relevant information.
- Identifies safety signals based on the review of solicited or unsolicited single case reports, aggregate data and signal detection tools (ie EMPIRICA) and performs signal evaluation and monitoring.
- Prepares clinical expert statements related to signal evaluation (eg literature, clinical; non-clinical, epidemiology).
- Responsible for review of study protocols (including MRC or OPRC if applicable).
- Responsible for medical input to aggregate clinical safety regulatory reports (eg, PSUR, DSUR).
YOUR EXPERIENCE:
- MD
- At least 5-7 years of experience in Global Drug Safety (preferably Big Pharma)
- Broad experience in safety regulations and requirements; desirably knowledge of trials in oncology
- Good writing skills (aggregated safety reports etc.)
- Leadership (leading international cross functional teams); preferable candidates who worked as well already in other areas outside of Safety before (eg, Clinical, Medical affairs etc.)
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
Please note there is a job description available on request.
We hope that the role will be of interest to you and understand that further information may be required prior to an application to the end client, please feel free to email or call me at anytime with any questions you may have.
Looking forward to hear from you soon,
Kind regards,
Neha Sharma
Pharmaceutical & Life Sciences Business Developer
Recruiting Team MBA,
Michael Bailey Associates
Key words: Quality, Pharmacovigilance, safety management, life cycle management,EMPIRICA, PSUR, DSUR, MRC, MAP, OPCE, RAP, ICF, IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, Drug safety, epidemiology, Argus, regulatory, clinical trials, Basel
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Medien/Design