Senior PV Physician I

Ergomed

Job Location:

Sarajevo - Bosnia and Herzegovina

Monthly Salary: Not Disclosed

Posted on: 25-10-2025

Vacancies: 1 Vacancy

Job Summary

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 requiredby Company or Client.

For the Client (may include but is not limited to the following):

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 complete the adverse event tracker for all ICSRs reports

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

Can act as EEA QPPV and/or Deputy for up to 2 clients if required.

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 preparationof reference safety information Company Core Data Sheet)

Actively participate in the Drug Safety Review Committee - signal detection and risk evaluation process for Client company medicinal products in the products life cycle. Serves on Clients advisory and scientific committees.

For the Company (may include but is not limited to the following)

To support the preparation of PV procedures

To provide training and mentoring of junior PV Physicians

To provide medical advice and input to project teams on daily basis

Continuously working on the development of the procedures on the company level

Preparing or contributing to the preparation of signalling related company procedures

The Senior PV Physician will support the Director of Projects as well as the QPPV on a day to day basis as needed

Supporting the Medical Director in training and mentoring on signalling activities

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)

Additional Information :

Why PrimeVigilance

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

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

Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!

Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships

Come and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application.

Remote Work :

Yes

Employment Type :

Full-time