Medical Director (Pharmacovigilance) Bucharest

Medical Director (Pharmacovigilance)
Bucureşti
Bucharest, Bucharest, Romania

Job Description

The Medical Director will lead, educate, mentor and develop the team of PV physicians to ensure their competence and confidence in developing their skills to become subject matter experts in pharmacovigilance. The role requires active monitoring of costs and project deliverables and interacting with the pharmacovigilance operational team. The Medical Director has a senior managerial/leadership position and ensures that all contracted PV physician activities are managed in compliance with regulations and company policies/procedures and in accordance with any PV agreements.

For the Client:

• Assignment of the PV physicians to client projects and ensuring quality, compliance, and efficiency

• Acting as the point of contact with any Client issues. Maintaining good client relations and ensuring a consistently high quality of work for each client, creating trust in our expertise and services.  Attending regular client meetings to present/discuss safety data received/reviewed.

• Ensuring the integration, analysis and interpretation of safety information collected from preclinical through to
- marketing, including medical review of individual case safety reports, signal detection and validation, aggregate report review and risk/benefit analysis

• Providing expert safety input to the clinical development program for some client projects while giving expert medical input to clinical trials

• Ensuring that Investigator’s Brochures, Clinical Study Protocols and Study Safety Plans/Joint Operating Procedures include a formal check of all areas related to PV Physician related activities as outlined in the client contract.

• Reviewing or drafting responses to requests on all drug safety matters from Competent Authorities in the EEA and to assist in the preparation of reports to other CA’s

• Involvement in the development/review of Risk Management Plans/ Periodic Safety Update reports/Developmental Safety Update Reports and other aggregate/ad hoc reports for client company products. • Actively participating 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.

• If required, provides high level consultancy to clients on issues relevant to medical aspects of pharmacovigilance

For the Company:

- Oversees and manages the group of pharmacovigilance physicians and is responsible for the quality, compliance, and timeliness of their work

- Working
- functionally with multiple disciplines to provide guidance on productive cross functional medical safety collaborations for clients

- Support quality and efficiency strategies within the organisation

- Creates strategy for the team, ensuring adherence by contributors via oversight of metrics reports.

Oversees key performance indicators of deliverables prepared by key stakeholders, e. g. , Clients, compliance team, quality team

- Supporting and overseeing development of
- based assessments and mitigation plans and its execution within medical department

- Ensuring appropriate escalation of potential quality issues to other senior management and its follow up till resolution

- Support the Business/Commercial team in pharmacovigilance medical aspects of the development ofcontracts and proposals

- Support the Company by attending bid defense meetings and conferences as the medical expert, as required

- PV medical training presentations and delivering PV medical training as required

- Developing of medical SOPs based on the Company needs and regular updates of the existing SOPs within the applicable targets

- Maintains Prime
Vigilance awareness of developments in the scientific and medical aspects of pharmacovigilance and pharmacoepidemiology by reading and attending external seminars and conferences

- Acts as EEA QPPV and/or Deputy for up to 2 clients if required.

• The Medical Director should be medically qualified as a physician; ideally a higher qualification also or a postgraduate qualification relevant to pharmacovigilance or pharmacoepidemiology
• Minimum of 15 years of experience including experience in clinical research as well as pharmacovigilance is required
• Experience with leading or supporting the proactive monitoring and evaluation of all aspects of the safety profile of designated products and ensure that optimal decisions are made, relating to signal detection activities, safety signal evaluations, updates to product labelling documents, responses to regulatory agency enquiries and product quality issues
• Experience in reviewing of different aggregate report types including PADERs, PBRERs, DSURs, Annual Safety reports and RMPs is mandatory
• Experience as a Qualified person for pharmacovigilance is essential
• Prior experience in supporting business development activities and bid defence meetings
• Previous experience with authoring/reviewing PV procedures is mandatory
• Prior experience managing multiple strategy formulations
• Experience with Pharmacovigilance processes and global Pharmacovigilance regulations
• Leadership and managerial experience, positive track record of success 
• Comprehensive knowledge of and practice in global Pharmacovigilance regulatory environment

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!

#LI remote