Regulatory Specialist

Vor 2 Tagen

Frankfurt am Main, Deutschland PrimeVigilance Vollzeit

Company Description

Founded in 1997 by two Medical Doctors, Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials. Ergomed provides services to over 100 clients in a range of therapy areas but excels in executing complex trials for new Rare Disease, Oncology and Neuroscience treatments.

**Job Description**:
The Specialist, Regulatory and PV network will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for regulatory and pharmacovigilance activities.

The Specialist will also act as local contact person for the designated country.

**Responsibilities**:

- Ensure the effective and rapid coordination and management of project deliverables to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
- Provide Clients expertise and guidance at national level.
- Set-up and coordinate the network of local contact persons(LCPs) for RA and PV in assigned projects
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
- Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
- Manage LCPs training and assess key performance indicators
- Act as main point of contact with the clients for Regulatory and PV network activities
- Managing project budget including vendor costs
- Act as primary contact person for local regulatory authority / Pharmacovigilance expert in assigned countries
- Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
- Provide feedback on performance of vendors to aid their assessment.
- Review and linguistic input on local Product Information and Mock-ups
- Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information

**Qualifications**:

- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
- Previous experience within the pharmaceutical/CRO industry
- PV training and/or working experience and other educational or professional background as required locally
- Fluent in English and German, both written and verbal
- Good planning and organizational skills
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Good attention to detail

Additional Information
**Why Should You Apply?**
- You want be involved in a wide range of interesting projects and studies
- You'd like your achievements and hard work to be recognised
- You want to work for a growing company where there are opportunities for advancement
- You'd like to work in a company that has a great reputation with its clients and employees.
- Making a difference to people's lives matters to you

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