Full-Time Senior Specialist, Regulatory & PV Network
Ergomed is hiring a remote Full-Time Senior Specialist, Regulatory & PV Network. The career level for this job opening is Experienced and is accepting Prague, Czech Republic based applicants remotely. Read complete job description before applying.
Ergomed
Job Title
Senior Specialist, Regulatory & PV Network
Posted
Career Level
Full-Time
Career Level
Experienced
Locations Accepted
Prague, Czech Republic
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Job Details
The Senior Specialist, Regulatory and PV Network is responsible for developing strategy and driving regulatory and PV deliverables. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants. The Senior Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.
Job Responsibilities
- Act as Local Contact Person for Pharmacovigilance.
- Assume leadership for projects ensuring effective coordination and management of regulatory deliverables.
- Develop strategy and manage set up activities.
- Provide strategic input to internal and external customers and promptly identify and address any risk.
- Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
- Ensure correct training assignment and compliance by the LCPs
- Prepare client’s invoices and review/approve vendors’ project invoices
- Provide training, coaching and mentoring to junior members of staff
- Foster professional working relationships with internal and external contacts.
- Stay abreast of changing regulatory legislative requirements.
- Participate in and/or support junior members in preparation for audits/inspections.
- Track LCPs' key performance indicators and prepare monthly summary reports
- Provide feedback on performance of vendors.
- Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
Qualifications
- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
- Strong experience within pharmaceutical or CRO industry or Regulatory body
- Good knowledge of ICH GCP and/or GVP and national regulations
- PV training and/or working experience
- Fluent in English, both written and verbal
- Proficiency in German, French, or Italian is a plus
- Good planning and organizational skills
- Strong interpersonal skills
- Good attention to detail
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Senior Specialist, Regulatory & PV Network at Ergomed is
19th of December 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Prague, Czech Republic
] applicants. .
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