Associate Medical Director
- Guildford, UK
- Employees can work remotely
PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.
Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report.
This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.
The position has primary responsibility for ensuring that the PV activities performed by assigned PV physicians are managed in a cost-efficient manner, of the highest quality and in compliance with global regulations and company policies/procedures and in accordance with any PV agreements. 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 project managers, project directors and the senior operational team.
The Medical Director is responsible to ensure that all contracted PV physician activities are managed in compliance with regulations and company policies/procedures and in accordance with any PV agreements. Additionally, the role must include review and implementation of efficiency strategies whilst maintaining the highest quality of work.
For the Client
- Assignment of the PV physicians to client projects
- Ensuring adequate and appropriately qualified physician resources across client projects
- Acting as the point of contact with any Client issues as required
- Ensuring quality, compliance and efficiency for physician activities within a Client project
- Ensuring the integration, analysis and interpretation of safety information collected from preclinical through to post-marketing, including medical review of individual case safety reports, signal detection and validation, aggregate report review and risk/benefit analysis
For the Company:
- Oversees and manages a group of pharmacovigilance physicians and is responsible for the quality, compliance and timeliness of their work
- Working cross-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 risk-based assessments and mitigation plans and its execution within medical department
- Ensuring appropriate escalation of potential quality issues to senior management and its follow up till resolution
- Support the Business/Commercial team in pharmacovigilance medical aspects of the development of contracts and proposals
- Support the Company by attending bid defence 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 PrimeVigilance 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.
- Provided that other work commitments do not prevent this, participates in external symposia and conferences, including speaking / presenting papers at these events; when feasible, writes / co-authors contributions to professional journals and other publications
- Participates in the training of PrimeVigilance physicians and is responsible for maintaining and developing their level of professional interest and expertise
- Contributes to external professional training programmes such as organised by the University of Hertfordshire, ISOP, the DSRU, DIA etc.
- The Associate Medical Director should be medically qualified as a physician; ideally a higher qualification also or a postgraduate qualification relevant to pharmacovigilance or pharmacoepidemiology
- Strong 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
- Excellent organisational, interpersonal and communication skills.
- Excellent Leadership skills with the ability to influence with credibility both externally as well as at all levels of a matrix organisation
- Ability to present complex data/information at all levels of the organisation and externally
- Good decision making and problem resolution based on all relevant information.
- Strategic thinking, recognising key issues and providing practical solutions
- Analytical thinking, with proven ability to lead analysis of safety data whilst applying sound medical judgment
- Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities.
- Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills
Excellent verbal and written communication (in English)
Advanced knowledge of MS Office (word, power point, excel)
All your information will be kept confidential according to EEO guidelines.
- Work within a successful, highly – qualified and dynamic team
- Professional training and career development in a fast-growing healthcare company