Senior PV Physician I Bucharest

Senior PV Physician I
Bucureşti
Bucharest, Bucharest, Romania

Job 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 requiredby Company or Client.

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

To review and approve
- 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,
- 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 product's life cycle. Serves on Client’s 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

• 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
  - culturally and
  - functionally and value the importance of teamwork
• Communication skills  
• Presentation skills
• English - advanced (spoken, written)
• Advanced literacy (MS Office)

Why Prime
Vigilance 

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a
- 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 Prime
Vigilance 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 patient’s lives. We look forward to welcoming your application.