Senior Medical Information and Pharmacovigilance Specialist & Deputy Local Safety Officer
Senior Medical Information and Pharmacovigilance Specialist & Deputy Local Safety Officer
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Job Description
Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.
We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.
At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.
Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.
Job Title: Senior Medical Information and Pharmacovigilance Specialist & Deputy Local Safety Officer
Location: London UK
Purpose of the Job:
Take the lead in adverse event and medical information management and support the Head of Pharmacovigilance in pharmacovigilance compliance activities in accordance with Good Pharmacovigilance Practices (GVP) and local and international regulations.
Key Responsibilities:
- Mailbox management and triage of reports to identify AEs MIs and PQCs.
- Logging and responding to medical information enquirys using documentation and resources available according to relevant Standard Operating Procedure (SOP)/ Work Instruction (WI) and regulatory guidelines.
- Logging and following up adverse event reports according to relevant Standard Operating Procedure (SOP)/ Work Instruction (WI) and regulatory guidelines.
- Mailbox management.
- Ensuring compliance with Good Pharmacovigilance Practices (GVP).
- Contributing to follow-up requests from Global PV.
- Act as pharmacovigilance representative when working cross-functionally.
- Support the Local Safety Officer with pharmacovigilance activities to ensure compliance to local regulations and guidelines.
- Market research activity oversight
- Reconciliation
- SOP and WI writing
Profile Requirements and Competencies:
Key Skills / Experience Required:
- Medical pharmacy or bioscience degree
- 36-year pharmacovigilance experience (Pharma or Biopharma)
- Experience with adverse event case management
- Involvement in some and very good understanding of local pharmacovigilance activities (market research compliance monitoring reconciliation etc)
- Customer service experience (not essential)
PERSONAL ATTRIBUTES (see profile requirements above - plus)
- Excellent communication skills verbal and written
- High level of personal accountability and can-do attitude
- Problem solving
- Attention to detail
- Ability to manage your own workload and priorities
Required Experience:
Senior IC
Employment Type
Full-Time
