Pharmacovigilance Manager
- Denmark
- Permanent
- Drug Safety / Pharmacovigilance
This vacancy has now expired
Our client is a biotechnology research company, which is focusing on metabolic diseases like diabetes and obesity.
Duties and responsibilities will include but not limited too:
- Development and execution of the safety surveillance strategy and activities for the projects assigned
- Execution of signal detection activities, to support the evaluation and decisions of our client.
- Preparation of high quality periodic safety reports (DSUR, periodic SUSAR reports)
- Preparation of Risk Management Plan (RMP) and/or Risk Evaluation and Minimization Strategies (REMS) documents
- Support the design and execution of the assigned clinical programs from a clinical safety perspective
The successful candidate will have:
- MD degree
- At least 7 years of in-depth, hands-on work experience with drug development in general and in particular with drug safety/pharmacovigilance processes applied in safety surveillance (safety analysis, signal detection and management, DSUR/PSUR, RMP/REMS, internal safety committees, communication with regulatory authorities)
- Solid understanding of the PV (EU and FDA) requirements
- Strong analytical skills
- Ability to communicate and interact maturely with internal and external stakeholders
- Strong ethical standards
- Quality mind-set
- Team-player mindset
We are looking for candidates who are able to provide drug safety expertise to project teams, including all relevant documents prepared for regulatory submissions for the assigned clinical programs.
We are offering a highly competitive salary and benefits package for this position.
If this is of interest please do get in touch.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
To view Quanta's privacy policy, please visit our website
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Save as job alert
Similar Jobs
Salary
Competitive
Location
Hertfordshire
Salary
Competitive
Sector
Drug Safety / Pharmacovigilance
Job type
Permanent
Location
South East
Description
Senior Pharmacovigilance Manager – Biopharmaceuticals - Hertfordshire / Remote Our client, a global biopharmaceutical company with plants across Europe and North America is looking for a Senior
Reference
31656
Expiry Date
01/01/0001
Author
Kathryn TaylorAuthor
Kathryn TaylorSalary
Competitive
Location
Remote work
Salary
Competitive
Sector
Drug Safety / Pharmacovigilance
Job type
Permanent
Location
Remote
Description
Clinical Safety Manager – Life Sciences – Permanent – Remote (UK or Europe) Our client, a prominent consulting and solutions firm specialising in risk management and compliance services for
Reference
31473
Expiry Date
01/01/0001
Author
Kathryn TaylorAuthor
Kathryn TaylorSalary
Competitive
Location
Central London
Salary
Competitive
Sector
Drug Safety / Pharmacovigilance
Job type
Permanent
Location
London
Description
Regulatory Affairs Specialist - London - 12-Month Contract Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this
Reference
33886
Expiry Date
01/01/0001
Author
Kathryn TaylorAuthor
Kathryn TaylorInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Kathryn
I manage this role.