Do you have thorough pharmacovigilance knowledge and are looking to apply it?
Are you looking for an opportunity to maintain the Pharmacovigilance System Master File (PSMF)?
Are you located in Munich, Germany, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a pharmaceutical organisation, specialising in creating and supply innovative pharmaceutical products. Operating worldwide, our client is committed to saving lives.
Our client is seeking a self-starter to ensure the safety and operational standards within the pharmacovigilance department are maintained and fulfilled.
Discover more about our Quality Control Manager Pharmacovigilance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Quality Control Manager Pharmacovigilance, you will be measured against the following objectives:
1) Defining, managing, maintaining, and coordinating procedures to continuously improve quality.
2) Supporting in the creation, revision, and maintenance of relevant PV agreements.
3) Conducting GVP/PV Audits and inspection preparation.
What you will do:
As the Quality Control Manager Pharmacovigilance, your duties and responsibilities will include:
- Defining, managing, maintaining, and coordinating procedures to continuously improve quality in collaboration with the departmental and global groups.
- Ensuring the safety and operational standards within the pharmacovigilance department are maintained and fulfilled.
- Containing the control of quality tasks within the department and related tasks performed by affiliates, license partners and CROs.
- Maintaining the Pharmacovigilance System Master File (PSMF) and related documents.
- Supporting the department regarding GVP/PV audit and inspection preparation and follow-up of CAPAs regarding deviations and findings of inspections audits.
- Coordinating and supervising PV audits contracted to external auditors, including the selection of external auditors.
- Hosting and following-up with authority inspections, especially in PV / safety topics.
- Providing expert advice in Good Pharmacovigilance Practice (GVP).
- Providing GVP support, advice, education, and training to other departments involved in clinical trials and PV activities.
What you will bring:
These are the skills and experience you will need to succeed as the Quality Control Manager Pharmacovigilance:
- An analytic and systematic approach with good problem-solving skills.
- First-rate communication and interpersonal skills.
- Fast learner, adaptable and excellent cross-collaboration skills.
- A hands-on individual who enjoys challenges and is dedicated to getting the job done.
- A “can do” attitude and a willingness to achieve personal and organisational goals.
- Thorough knowledge of Pharmacovigilance (at least 5 years), additional skills/experience in other GxP areas are an advantage.
- Master’s degree in Life Sciences, Pharmacy or Medical Sciences preferred.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Subsidised travel.
- Subsidised lunches.
Got what it takes?
To apply for the Quality Control Manager Pharmacovigilance, click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – 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.