Senior Pharmacovigilance Physician I Bucharest

Senior Pharmacovigilance Physician I
Bucureşti
Bucharest, Bucharest, Romania

Job Description

For the Client

To review and approve
- marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and
- up questions.

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 provide input in Periodic Safety Update Reports, Development Safety Update Reports, 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 the preparation of responses to regulatory authority requests

Signalling

Reviewing line listings

Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation

Evaluating and categorizing possible signals and proposing a course of action

Supporting preparation and review of
- risk reports

Signalling

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

Evaluating and categorizing possible signals

Proposing a course of action whenever a possible signal is identified

Supporting preparation and review of
- risk reports

Supporting PV Project Managers in the planning of signalling schedule and resources

Supporting PV Project Managers in the preparation of
- specific working instructions regarding signalling

Overseeing the quality of signal detection activities and providing quality and compliance metrics to the Quality Department

For the Company 

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

Training, mentoring and managing junior PV Physicians

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.