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Senior Manager Pharmacovigilance

Employer
Hobson Prior
Location
England, Surrey
Salary
GBP60000 - GBP65000 per annum
Start date
22 Sep 2021
Closing date
21 Oct 2021

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Discipline
Clinical Research, Pharmacovigilance
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Job Details

Hobson Prior are currently working with a growing global specialist healthcare company who are focused on developing and commercialising products targeting acute care, oncology and vascular diseases. Our client is looking for a Senior Manager Pharmacovigilance to join them on a 12 month fixed term and within the UK.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • Day to day management of PV Team.
  • Ongoing monitoring of the safety profile of the MAH`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.
  • Ensure departmental compliance with EU & Global pharmacovigilance regulations.
  • Support internal customers in safety issues, i.e. participate in safety sections of development protocols, review of labelling updates, assessment of the partners for PV audits and compliance with SDEAs, etc.
  • Proactively manage outsourced activities with QPPV provider and pharmacovigilance vendor and ensure they are incompliance with the standards of quality, vendor established KPIs and EU and global pharmacovigilance regulations.
  • Lead Global Safety Review Committees (GSRC) and escalate safety signals, formulate required actions and ensure key stakeholders are informed.
  • Responsible for the safety strategy during drug development, including development and implementation of RMPs, and monitoring and analysis of cumulative safety information in the context of the benefit-risk profile.

Requirements:

  • 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.
  • Experience of managing outsourced activities.
  • Proficient in developing and implementing programs and policies.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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