Back to Remote jobs >
All others
Senior PV Physician I
@Ergomed
[Hiring] Senior PV Physician I @Ergomed
Mar 23, 2025 - Ergomed is hiring a remote Senior PV Physician I. 💸 Salary: unspecified. 📍Location: Bulgaria.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, writing and/or reviewing aggregate reports (DSURS, PSURS, PBRERs, PADERS), reviewing risk management reports (RMPs), and mentoring junior PV Physicians.
The Senior PV Physician I is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client.
- To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment.
- Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required.
- Including completion of all required supporting documentation such as trackers.
- To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues.
- To review and approve literature screening search strategy.
- To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings.
- To cooperate in the preparation of and provide input in Risk Management Plans.
- Supporting/to lead the preparation of responses to regulatory authority requests.
- To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, ACOs or Annual Safety Reports.
- To act as Company Lead in a specific pharmacovigilance area requiring medical input (e.g. for preparation of reference safety information – Company Core Data Sheet).
- Participating in signal detection activities including meetings, reviewing of signal detection reports, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation.
- To provide training and mentoring of junior PV Physicians.
Qualifications
- The PV Physician should be medically qualified as a physician.
- Previous experience in pharmacovigilance.
- Ability to review different aggregate report types including PBRERs and DSURs.
- Expertise in signal detection activities is essential.
- Excellent interpersonal skills.
- Ability to plan, organise, prioritise and execute multiple tasks.
- Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork.
- Communication skills.
- Presentation skills.
- English - advanced (spoken, written).
- Advanced literacy (MS Office).
Benefits
- Training and career development opportunities internally.
- Strong emphasis on personal and professional growth.
- Friendly, supportive working environment.
- Opportunity to work with colleagues based all over the world, with English as the company language.
Similar Remote Jobs
More jobs at Ergomed
More Medical jobs
-
All others from $285000/yr USAMar 26, 2025 -
All others $200,000 to $226,000 annually, plus 20% bonus USAMar 26, 2025
More jobs in Bulgaria
-
All others unspecified BulgariaMar 26, 2025
-
Sales / Business commission-based Northern America, Americas, Latin America (LATAM) +73 moreMar 25, 2025
Kickstart Your Job Search
Need advice to apply?
Join our free
Webinar « 3
Mistakes to Avoid When Looking For A Remote Startup Job (And What To Do Instead) »
Register for free
Unlock 53,432 additional remote jobs, advanced search & email notifications
Get Access Now
Too many emails? Declutter your inbox with Meco
Your home for reading newsletters
Try for free - no card required.
️
| 📍 | Be aware of the location restriction for this remote position: Bulgaria |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
unspecified
|
Remote
Location
Bulgaria
|
|
Job Type
full-time
|
Posted
Mar 23, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: Bulgaria |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
