Head of PV, Deputy EUQPPV
Do you have experience within a Pharmacovigilance environment?
Do you have previous experience with APIS & have the ability to become the deputy QPPV?
Are you a German Speaker & based in Munich?
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. Operating in Germany, they are committed to creating a better world for patients.
Our client is seeking a Technical PV leader to provide support to the EU Qualified Person for Pharmacovigilance.
Discover more about our Head of PV, Deputy EUQPPV opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
Your objectives:
As the Head of PV, Deputy EUQPPV, you will be measured against the following objectives:
1) Responsible for acting as the local Pharmacovigilance Response Person (LPVRP) & graduated plan officer Pharmacovigilance officer according to German Medicine Law.
2) Provide Support to the EU Qualified Person for Pharmacovigilance (EU QPPV).
3) Act as EU QPPV deputy in case of absence or leave of the EU QPPV.
What you will do:
As the Head of PV, Deputy EUQPPV your duties and responsibilities will include:
· Set up and maintain an effective pharmacovigilance system within Germany in compliance with national regulations and with PV procedures.
· Including Regular meetings with Global PV and EU QPPV.
· Support creation, maintenance and/or implementation of global/regional/local PV SOP’s and WG’s as well as SDEA’s.
· Interaction with external stakeholders (e.g., partner, vendors).
· Ensure proper documentation and archiving of all PV relevant information.
· Ensure appropriate contact with Country General Manager and other relevant local interfaces, such as Regulatory Affairs, Quality Assurance, Commercial, Legal, Medical Information.
· Provide PV trainings of all German employees and oversee training status.
· Act as the key contact (Graduated Plan Officer/Stufenplanbeauftragter) for German Regulatory Authorities regarding any PV issues.
· Monitor national regulations for any changes and adapt the local PV system accordingly.
· First line contact for national PV inspections by the German HA (BfArM) as well as for internal PV audits.
· Support of the EU QPPV with establishing and maintaining a compliant PV system across the EU.
· Support improving / maintaining the core PSMF with focus on the PSMF for the EEA/EU countries.
· Support the EU QPPV in internal audits and HA inspections (preparation, conduction and CAPA planning/fulfillment).
· Act as Deputy EU QPPV in case of planned or unplanned absence of the EU QPPV.
· Act as Deputy Information Officer according to §74a AMG to ensure medical information and advertising material complies with marketing authorization as well as with further applicable legislation (Drug Advertising Law, German Drug Law, Law on Unfair Competition etc.).
· Oversight of local processing of spontaneous reported adverse events, literature reports or any other safety-relevant information. This includes:
· Information exchange between Global PV or contractual partners.
· Collection of follow up information incl. response to the initial reporter.
· Reconciliation (internal and with external contractual partners).
· Tracking, documenting and archiving any safety-relevant information.
· Monitor timely submission of reportable cases (via Eudravigilance). Provide support for reviews of reports as needed.
What you will bring:
These are the skills and experience you will need to succeed as the Head of PV, Deputy EUQPPV:
· Life Science University Degree
· 4-5 Years Industry Experience
· Attention to Detail
· Excellent Communication Skills
· Pharmaceutical Background Knowledge
· Inspire & Lead Team in a collaborative manner
· Initiate & Lead quality improvements
· Resolve critical issues
What you will get:
These are the perks and benefits that will complement your generous base salary:
· Base Salary upto €115,000
· 20 % Bonus
· Life Insurance
· Health & Wellbeing Fund
· Vouchers
· Car Allowance
Got what it takes?
To apply for the Head of PV, Deputy EUQPPV, click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – on +44 (0)203 355 7050.
Please Note:
· 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 ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
· We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: https://www.fraserdove.com/privacy-policy/
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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.
