Safety Information Specialist

Job Description:

Safety Information Specialist, UK & Ireland

At Ferring Pharmaceuticals, we help people around the world build families and live better lies. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.

Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organisation and as professionals. Together we can influence the world around us to make life and work better.

Ferring+You

You will

• Work cross-functionally where needed to resolve queries

• Manage communication with the health authorities

• Provide information to Global teams

• Review and update SOPs within our area of work

• Generate reports on Safety, Product Quality Complaints and Quality

• Act as back up for the PV/Safety and for QA responsibilities of Head of RQS

• Act as backup for the Archivist

• Ensure compliance with the requirements of Good Distribution Practice (GDP) and Good Pharmacovigilance Practices (GVP)

• Comply with GDP and GVP and all applicable regulations

Your day at Ferring

Safety / Pharmacovigilance

• Act as the Local Safety Officer (LSO) for Ireland and Malta

• Perform the back up for PV/Safety and QA responsibilities of Head of RQS and UK LSO/UK QPPV deputy

• Primary contact to Global Safety regarding pharmacovigilance and device vigilance.

• Ensure fulfilment of responsibilities according to the internal agreement between LSO and Global Safety.

• Ensure fulfilment of responsibilities according to global procedure QD-00000976 (QPPV and Local Pharmacovigilance Responsible).

• Management of UK and Ireland Safety mailboxes

• Process and report to Global Safety or/and Health Authority for all related safety information received from all sources including market, post-authorisation studies, scientific literature according to global procedures.

• Local processing of safety information, such as the reporting of adverse events received by Ferring UK and Ireland to Global Safety. Maintain the case log, manage queries related to Safety. Conduct monthly reconciliation with Global Safety and vendors/ third parties and resolve ant discrepancies.

• Identify and document Safety deviations from both internal and external sources.

• Filing of Safety information documentation, including source data and follow-ups for cases and other documentation.

• Ensure pharmacovigilance reporting timelines are maintained. Arrange for suitable, trained cover when unavailable.

• Manage communication with the health authorities, as required.

• Facilitate the drafting and signing of Pharmacovigilance Agreements with relevant partners, including vendors and third parties, ensure comprehensive coverage in compliance with global and local requirements.

• Management of the PV/ Safety aspects of Patient Support Programmes, Digital Programmes and or Market Research Programmes. Ensure adequate PV requirements and arrangements for safety data collection are in place, 3rd party training has been performed and reconciliations are completed.

• Provide Safety data, including information for the EU PSMF, to Global Safety upon request

• Effectively support the business with PV/ Safety related activities

• Provide information to the UK QPPV upon request

• Monitor and contribute to the maintenance of the UK Pharmacovigilance System Master File (PSMF) and annexes

• Support inspections from regulatory agencies

• Support audits from other Ferring auditors, agencies and partner companies where required.

• Ensure all employees and vendors have up-to-date PV/ Safety training.

• Review and update Safety training slides annually or as required.

• Provide appropriate Safety training slides to employees and vendors and monitor completion on time

• Create PV/Safety reports to summarise PV/Safety activities for the UK and Ireland

Product Quality Complaints

• Management of all complaints and coordinate with local and global functions, Healthcare Professional (HCP), Health Authority (HA) related to product quality complaint.

• Manage Complaints in a timely and effective manner according to procedures and the global process, ensuring PQCs are closed in a timely manner.

• Management of UK and Ireland mailboxes for Product Quality Complaints

• Maintain accurate UK and Ireland PQC logs

Quality Assurance

• Support colleagues with SOPs, Quality Docs SOP template format and technical information

• Track and chase regular SOP updates by Document Owners

• Act as a Document Controller in Quality Docs for SOPs

• Log the products received at the UK pre-wholesaler and third parties in the UK, Ireland and Malta, manage Certificates of Analysis and Conformance, filing. Maintain the Responsible Person for Import (RPI) weekly checks on the incoming goods tracker and share with the RPI for the monthly review

• Monitor and file temperature data, manage excursions. Investigate and provide disposition of transport excursions in a timely manner

• Monitor and support the closure of the Quality Management System (Trackwise) records by colleagues

• Generate or contribute to the quarterly Quality Performance Indicator (QPI) data and Quality reports, including the annual Quality Review Board report

• Support the preparation activities for inspections and audits

• Review, archive and destruction activities for RQS records

• Back Up for Archivist

Behind our innovation…There’s you

Required Education/Qualifications/Skills:

• Bachelor in life sciences

• 2-3 years in pharma or quality or pharmacovigilance role

People come first at Ferring

• Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love

• Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role

• Parental leave for both birthing and non-birthing parents

• Extended support on family building journey

Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You.

Behind our purpose… There’s you

If our mission and your vision are aligned, please apply!

We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.

Location:Ferring UK