Sr. Manager Pharmacovigilance (Fixed Term Contract)

Come and Save Lives with Us!

The Company is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 400 employees in 16 countries.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority    
• We act with integrity and accountability 
• We work together as one team  
• We look for better ways forward

Broad Overview

Manage BTG’s Pharmacovigilance System.  Maintain the overall safety profiles and any emerging safety concerns in relation to the pharmaceutical products for which BTG holds authorisations.  Responsible for all pharmacovigilance risk management issues for the BTG products as well as acting as UK National Contact Person for SERB and UK QPPV for Veriton.

As a Sr. Manager, Pharmacovigilance, some of your responsibilities will include:

Day to day management of BTG PV Team.

Ongoing monitoring of the safety profile of the BTG`s medicinal products and continuous overall safety evaluation during the post-authorisation period.

Oversight of Individual Case Safety Reports (ICSRs), Standards Operating Procedures (SOPs), aggregate reports (PSURs and PADERs) and Safety Data Exchange Agreements (SDEAs).

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.

Audit/inspection readiness for the PV audits, ensuring successful audit/inspection outcomes and ensuring findings are appropriately addressed and closed timely.

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.

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

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To be successful in this role, you should demonstrate:

A medical or Life Science Degree

Minimum 5 years experience in the pharmaceutical industry, with solid experience in pharmacovigilance

A good understanding of normal and pathological physiological function

Experience with product-oriented contact with doctors and patients

Company Benefits:

25 annual leave days plus bank holidays and 3 annual company closure days (to be taken between Christmas and New year)

Competitive Pension Scheme 

Private Medical Insurance

Discretionary Bonus Plan

Paid Maternity and Paternity Leave

Academic Study Assistance

Eyecare vouchers

Employee Assistance Programme

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.