Join Syner-Med: Where Innovation Meets Impact
At Syner-Med, we’re a growing company driven by a passion for advancing healthcare and making a real-world impact. With a focus on key therapy areas such as Women’s Health, Vascular Medicine, and Infectious Disease, we’re committed to addressing critical medical needs and improving lives.
Collaboration and innovation are at the heart of everything we do. Our people are united by a shared purpose to deliver exceptional solutions that empower healthcare professionals and create meaningful change for patients.
If you’re looking to grow in a dynamic, fast-paced environment where creativity, integrity, and collaboration are valued, Syner-Med is the place for you. Here, you’ll have the opportunity to make a difference in the world while advancing your career in one of the most impactful industries.
✨ Ready to join us? Explore opportunities with Syner-Med and help shape the future of healthcare.
Internal Job Title: Senior PV Officer
Office Location: Reigate, Surrey
KEY RESPONSIBILITIES:
* Daily Management and monitoring of 2x PV and x2 MI mailboxes.
* Maintenance of AE and MI trackers
* Triage and handling of weekly & monthly PV and MI reconciliation reports
* Review of Technical Agreements and responsible for end-to-end management of PV contracts, including SDEAs/PVA
* Triage/management of AE reports from International Partners and PV vendor.
* Handle PV email and telephone enquiries from HCPs and MoP
* Maintains the UK and EU PSMFs
* Maintains the Risk Management Plans
* Provides expertise on UK PV legislation to support both internal and external partners including requisite internal and external audits
* Perform monthly literature searches
* Maintenance of the Deviation/CAPA tracker
* Joint review with the PV vendor on pharmacovigilance documents including aggregate safety reports (PSURs etc.), Signal Management/detection reports, Post-approval and post-marketing commitments as applicable (e.g. Post-Authorisation Safety Studies)
* Ensures oversight of Business partners and vendor outsourced PV activities that may impact UK and global PV systems
* Interacts with UK, EU and local health authorities for PV when required
* Builds good working relationships with other departments and international partners, both in UK, globally and at European level
* Works alongside the UK/EU QPPV, PV teams to ensure performance and maintenance of the company pharmacovigilance system
* Oversees maintenance and implementation of ad hoc safety reports and PV tasks
* Provides input into urgent UK regulatory actions, audits/inspections and ensuring information is shared across PV organisation as appropriate
* Ensures that the relevant staff are trained effectively in PV to perform their roles and responsibilities via PV training matrices, in collaboration with the Quality Manager
* Continual compliance with all procedural requirements of the role
* Ensure PV and MI Standard Operating Procedures (SOPs) are compliant, in line with company requirements and up to date
* Provide technical and medical information to Healthcare Professionals and MoPs in response to email and/or telephone enquiries
* Create monthly metrics on assigned products
* Provide technical and medical information to HCPs and MoPs in response to email and/or telephone enquiries, which may include performing literature searches
* Create and maintain standard (e.g., MI Letters and Frequently Asked Questions, etc.) and custom responses to communicate disease state, product information, and other general information to internal and external customers
* Triage and handling of monthly MI reconciliation reports from partners
* Submission of weekly MI reconciliation reports to PV vendor
SKILLS/EXPERIENCED REQUIRED:
* Ideally at least 5 years of experience in PV environment and involved in PV audits/inspections
* Degree educated (Life Science degree preferred)
* Knowledge of MI enquiry handling
* Good leadership capability with developed skills in team building and motivating people
* In depth knowledge of local/UK and EU PV regulatory requirements (ie GPvP and GVP) regarding drug safety and a general understanding of drug safety methodologies to meet compliance standards in signal detection and evaluation, risk/benefit assessments as well as in the implementation of pharmacovigilance risk minimisation strategies
* Good communication skills to ensure effective dialogue with NHS stakeholders and members of the public
* Excellent team-work ability & strong interpersonal skills, including capability to engage in professional relationship building and networking
* Highly motivated and capable of comprehending technical content, which is communicated in clear, concise manner
* Demonstrate success in self-managing priorities and multi-tasking projects
* Ability to work effectively and share information within a team environment.
Your next big step starts here. Apply today and become part of a team that’s changing lives—one breakthrough at a time.
We aim to review all applications and provide a response within 2 weeks. If you do not hear from us during this time, unfortunately, it means your application has not been successful.