Pharmacovigilance and Medical Information Manager (QPPV)

ZipRecruiter; Hertford; Hybrid; GBP 45,000 - 70,000; Full time

Job summary

An ambitious pharmaceutical company is seeking a Pharmacovigilance and Medical Information Manager to lead compliance and safety evaluations. This role involves managing a dedicated team, ensuring adherence to regulatory standards, and overseeing the safety profile of medicinal products. The successful candidate will play a pivotal role in maintaining the highest quality of pharmacovigilance activities while contributing to the company's growth in new markets. Join a dynamic environment where your expertise will directly impact patient safety and the company's success.

Benefits

25 Days Annual Leave

Discretionary Annual Bonus

Comprehensive Private Medical Insurance

Structured Growth and Development Programme

Reward and Recognition Scheme

Qualifications

• 5+ years in the pharmaceutical industry with management experience.
• Strong knowledge of pharmacovigilance regulations in the UK and Europe.

Responsibilities

• Manage and maintain a compliant Pharmacovigilance system.
• Oversee Individual Case Safety Reports and audit readiness.
• Accountable for all strategic PV activities.

Skills

Pharmacovigilance

People Management

Regulatory Compliance

Organizational Skills

Interpersonal Skills

Problem Solving

Analytical Skills

Time Management

Education

Degree in Medicine or Life Sciences

Job description

Job Description

Pharmacovigilance and Medical Information Manager

Neon Healthcare is a fast-growing and ambitious pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and is looking to expand its activities into other markets.

Reporting to the Chief Technical Officer, this role supports the Pharmacovigilance and Medical Information Team with managing daily operations in compliance with regulatory requirements.

Description of Main Duties and Responsibilities

1. Organise, manage and maintain a highly compliant Pharmacovigilance (PV) system for Neon Healthcare.
2. Day to day management of the PV / MI Team (currently two direct reports).
3. Ongoing monitoring of the safety profile of our portfolio of medicinal products and continuous overall safety evaluation during the post-authorisation period.
4. Oversight of Individual Case Safety Reports (ICSRs), Standards Operating Procedures (SOPs), authoring aggregate reports (PSURs and PADERs) and Safety Data Exchange Agreements (SDEAs).
5. PV SME for Risk Management Plans (RMP), Post Authorization Safety Study (PASS) protocols, Risk Minimisation Strategies, effectiveness of follow-up measures, post-marketing commitment and e-transmissions to competent authorities.
6. Lead and coordinate internal and external PV audits and inspections.
7. Audit/inspection readiness for the PV audits, ensuring successful audit/inspection outcomes and ensuring findings are appropriately addressed and closed timely.
8. Ensuring the 5-year audit plan for pharmacovigilance is executed as planned, maintained on an ongoing basis and ensuring the pharmacovigilance system is fully audited on a rolling 5-year basis.
9. Author or review and sign off aggregate reports (PADERs and PSURs), Risk Management Plans particularly if they relate to drug safety, to assure that quality is maintained, and that benefit/risk information is accurate and not misleading.
10. Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as international regulations and guidelines for pharmacovigilance.
11. Ensure PV business continuity and after-hours availability.
12. Monitor PV system performance and compliance of partners and distributors.
13. Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country.
14. Accountable for all strategic PV activities for Neon Healthcare.
15. Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Neon Healthcare products and to meet regulatory requirements.
16. Act as the responsible contact person in the regions (i.e. Either QPPV or Deputy QPPV, Qualified Person for Pharmacovigilance), internally and externally, for safety-related aspects and PV.
17. Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.

Knowledge, Skills & Attributes

1. Minimum five years of working experience within the pharmaceutical / pharmacovigilance industry including experience as a people manager.
2. Degree or equivalent in medicine or in life sciences or equivalent experience e.g. Physician, Pharmacist, Nurse.
3. In depth knowledge of regional regulatory legislation and guidelines.
4. Knowledge of the pharmacovigilance regulations in the UK, Europe and Australia is required and other international markets is a plus.
5. Demonstrated ability to provide quality work using strong organisational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally.
6. Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
7. Capable of troubleshooting and managing multiple projects simultaneously.
8. Strong knowledge and understanding of medical terminology and clinical development processes.
9. Rational approach to issues and their business implications, good problem solving and decision making skills.
10. Highly organised, analytical with the ability to give attention to detail.
11. Possess excellent interpersonal, verbal, and written communication skills.
12. Work on own initiative for managing the day to day PV/MI activities.
13. Able to multitask and manage conflicting priorities with sound time-management skills.
14. Ability to identify compliance risks and escalate when necessary.

Salary and Benefits

1. 25 Days Annual Leave + an extra day annual leave per year (excluding bank holidays)
2. 40 hours per week inc of a daily 30-minute break (core hours 10am-4pm)
3. Discretionary Annual performance-based pay review
4. Discretionary Annual Bonus
5. Comprehensive Private Medical Insurance
6. Structured growth and development programme (post probation)
7. Reward and Recognition Scheme
8. Hybrid working available

Please apply via LinkedIn or email [e-mail]

Please note, we are not able to provide sponsorship. Applicants without a permanent UK VISA will not be considered and should not apply.