Job Description About PSC Biotech Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.
We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level' PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry.
We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression.
We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Role Functions · To provide specialist veterinary expertise on all aspects of the company's products and product markets and, in doing so, to actively contribute to sales support, product development and marketing within Ireland.
· To be a technical expert for the ruminant product portfolio in order to work with and support territory managers as well as having a good background knowledge of all the company's ruminant products.
· Priority is given to field-based support in this position; however support of product managers and their products will still be a requirement.
· It is expected that approximately 45% of the role will involve sales support, 30% marketing support and 25% customer enquiries/complaints.
· In the fulfilment of this position it is expected that duties will require a reasonable level of attendance at evening and weekend meetings, which may in some circumstances require overnight stays away from home.
i) To provide a support service to external customers.
Including: • answering queries regarding products and large animal health/welfare in general • investigating the background behind pharmacovigilance reports in order to ascertain the level of product causality to be reported to the relevant Competent Authority.
ii) To provide support to the territory managers with an aim to contributing to the sales activity.
Including: • calling on customers with Territory Managers • delivering presentations to customers and their clients to detail products and disease • support at a veterinary and farm level, including as a follow up to pharmacovigilance complaints and product quality complaints, to aid in the improved and correct use of products.
iii) To provide relevant support functions in pharmacovigilance and Product Quality Complaint (PQC) handling - including: • Recording of reports of Adverse Events or PQCs • Triage of reports before case entry into the pharmacovigilance database • Coding and assessment of cases in the pharmacovigilance database • Release of reports to comply with regulatory and company requirements • Entering follow up information into the pharmacovigilance database and release of these reports for approval to comply with regulatory and company requirements • To be aware of pharmacovigilance requirements, including legislative and company regulations and guidelines, to efficiently conduct these relevant duties iv) To provide support to the named product portfolios and Marketing/Product Managers with an aim to defend and grow market share and market presence.
Including: • identifying strengths, weaknesses, opportunities and threats (SWOT analysis) for the products • collating information from internal and external sources, to summarise and translate this information into differentiating points and position defence.
• proposing and managing trials to support the products.
• liaison with Regulatory Affairs to aid product licensing.
v) To ensure compliance within the APHA / NOAH Code of Practice and the Animal Remedies / Veterinary Medicines Regulations.
Including: • approval of material relating to the named product portfolio, ensuring it is consistent with all requirements.
• defending any challenges from competitors and, if necessary, representing the company at any hearing.
• monitoring competitor activity and challenge of breaches, initiating necessary correspondence and progressing to a satisfactory conclusion.
vi) To provide the company with comprehensive in-house technical training at various levels to ensure that all staff are trained to their necessary level on the large animal products and markets.
vii) To provide external communication at a technical level for the company.
Including: • technical representation at relevant meetings, congresses and exhibitions in order to promote the interests of the company amongst key industry influencers and opinion makers and to enhance the company's brand profile in the industry.
• presenting trials and providing written material or verbal presentations where required.
viii) To develop networks of benefit to the company.
including: • liaising with stakeholders regarding the future development of product markets, both in Ireland and other countries • developing working relationships within the Irish agricultural industry • development of relationships with key academic institutions and diagnostic companies, e.g.
Universities, Diagnostic Laboratories etc, in order to keep the company at the forefront of developing technologies.
Major challenges of the role are: • To accurately perceive and assess strategic opportunities for the company to support sales activity and actively input into commercial development.
• To provide a sound technical product servicing function, efficiently dealing with clients queries and complaints and balancing the best interests of the company with those of the client in the most cost-effective and yet ethical manner.
• To achieve the most effective allocation of time to the various accountabilities within the job holder's remit.
• To ensure all company literature reflects a true and accurate technical representation of the products and activity of the company.
Promoting the company and its products to all customers in an ethical and balanced way Requirements Strong Planning and Organising skills In-depth knowledge of the veterinary market In depth knowledge of pharmacovigilance legislation and guidelines Wide-ranging and sound communication skills Ability to work well within in a high performance team structure Ability to work under pressure to deadlines Sound interpersonal skills for dealing with a wide range of people in a variety of situations Ability to communicate (verbally and in writing) clearly and succinctly Self-starter with drive and focus Sound commercial acumen with high levels of integrity and trustworthiness Good presentation skills Sound IT and software skill Education & Qualifications Registered veterinary practitioner with at least three years' experience in general practice with a Relevant Industry Qualification.
Requirements Bring energy, knowledge, innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes.
Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
Support implementation and training for site Quality Systems and site GMP readiness activities.
Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
Support other QA colleagues, as required.
Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
Support gathering of site metrics Ensure the escalation of risks to management in a timely manner.