Do you have experience setting up and maintaining an effective PV system?
Are you looking for an opportunity to act as the deputy EU QPPV (Qualified Person Responsible for Pharmacovigilance)?
Are you based in Munich, Germany, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a leading pharmaceutical organisation specialising in the discovery of new molecules. Operating worldwide, they are committed to improving and enriching the lives of patients.
Our client is seeking a proactive individual to establish an effective PV system in compliance with regulations and act as the subject matter expert on PV issues for regulatory authorities.
Discover more about our Senior Pharmacovigilance Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Senior Pharmacovigilance Manager, you will be measured against the following objectives:
1) Strategically developing and implementing the local PV system.
2) Acting as the deputy EU Qualified Person Responsible for Pharmacovigilance (QPPV).
3) Ensuring PV is working more cross collaboratively both locally and globally.
What you will do:
As the Senior Pharmacovigilance Manager, your duties and responsibilities will include:
- Setting up and maintaining an effective PV system within Germany in compliance with national regulations and organisational procedures.
- Ensuring proper documentation and archiving of all PV relevant information to retrieve when needed.
- Acting as the key contact point for German regulatory authorities regarding any PV issues.
- Monitoring national regulations for any changes and adapt the local PV system accordingly.
- Acting as the EU QPPV deputy in cases of planned or unplanned absences of the EU QPPV.
- Monitoring timely submission of all reportable reports to national regulatory authorities.
- Overseeing and performing PV training of employees.
- Setting up and maintaining a local medical information system and answering medical enquiries from pharmacies and patients etc.
- Assisting in audits and inspections and adjusting PV system accordingly.
What you will bring:
These are the skills and experience you will need to succeed as the Senior Pharmacovigilance Manager:
- First-rate attention to detail and capability of seeing the bigger picture.
- Excellent communication and interpersonal skills.
- Confident decision-maker and ability to think strategically.
- Must be a native German or fluent in German.
- Deep understanding of PV systems with previous experience upgrading these systems to be more efficient.
- 6-8 years’ previous experience in PV within the pharmaceutical or biologics sector.
- Bachelor’s degree in Medicine, Pharmacy, Biology or equivalent.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Generous holiday allowance.
Got what it takes?
To apply for the Senior Pharmacovigilance Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Jason Cachia – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.