Regulatory Affairs And National Contact Person - PV - Manager

South East England Permanent
  • Hybrid Working
  • Fast Growing Pharmaceutical Business

About Our Client

My Client is a fast growing pharmaceutical business who own and commercialise branded , original over the counter products and prescription medicines. Products are available in more than 60 countries with EU and Nordic region as the core markets. Due to continuous growth and recent acquisitions we are looking for a Scientific Affairs Manager to join the team.

UK HQ based in the South East of England.

Job Description

Regulatory Affairs And National Contact Person - PV - Manager

Regulatory Affairs:

  • Manage launch compliance execution
  • Responsibility for the local product information and timely roll-out of label updates into the local market, including updates to texts, submission as applicable and implementation following approval. Duties are performed in collaboration and with support from Global functions.
  • Review and approval of local labeling (mock-ups) of the products.
  • Maintenance of local databases such as eMC, dm+d and medicines.ie.
  • Coordinate local regulatory activities for UK, IE, CA, AU/NZ, ZA and MT as instructed by the Global team
  • Diligently manage named patient basis in the UK. Duties include ensuring timely actions towards health care professionals to obtain consent, the manufacturer, MHRA and the importer of unlicensed medicine as well as internally handling both the duties related to both RA and QA.
  • Act as direct contact with UK Notified Body for medical devices marketed in UK.
  • Work with the global RA CHC (consumer healthcare) team towards compliance of the CHC portfolio on the UK market according to UK regulations for medical devices and cosmetics.



Pharmacovigilance

Govern Patient Safety interest in local marketing activities and mentor a vigilant mind set. Ensure that Local PV takes part in local brand teams "centre of attention".

  • Register with MHRA as the National Contact Person (NCP) for Pharmacovigilance.
  • Act as the nominated Local PV Contact Person (LPV) in the designated territory UK and Ireland.
  • Act as the CA contact person for PV in respective territory
  • Monitoring sources of receipt of AE and other safety information, which can include but is not limited to Fax, E-mail inbox, Telephone voicemail.
  • Collection and assessment of case reports (AE and other safety information) from various sources, translating, and forwarding to HQ in accordance with stipulated timelines
  • Identification of safety-related publications in the local scientific literature
  • PV intelligence locally
  • Supporting maintenance of the UK PSMF
  • Ensuring BCP locally and annual testing
  • Ensuring Annual Record Retention locally
  • Participate in the annual vendor review for the territories under responsibility (setting the tactical audit plan)
  • Upon request perform an annual PV training of local country managers, employees, marketing and sales partners, distributors, or other contractors, in respective territory.

The Successful Applicant

Regulatory Affairs And National Contact Person - PV - Manager

Equivalent qualifications acceptable for NCP candidates include:

  • 5 years' experience of local pharmacovigilance

Equivalent qualifications acceptable for RA:

  • Experience from regulatory affairs procedure and variation management

What's on Offer

Competitive Basic Salary + Package

Contact
Chloe Baverstock
Quote job ref
JN-032022-5375514
Phone number
+44 1727 730 144

Job summary

Sector
Life Sciences
Subsector
Regulatory Affairs
Industry
Healthcare / Pharmaceutical
Location
South East England
Contract type
Permanent
Consultant name
Chloe Baverstock
Consultant phone
+44 1727 730 144
Job reference
JN-032022-5375514