Instagram
youtube
Facebook

Pv Officer In Charge

2+ years
Not Disclosed
15 June 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Main responsibilities:

  • Replaces the CSH in most of his/her tasks when he/she is out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections.

  • Supports the CSH in ensuring that local PV activities are performed in compliance with the PSPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned country(ies)

 

  • Supports the CSH in ensuring establishment and maintenance of a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training

  • OPTION: Operates as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head

  • OPTION: acts as Local Safety Officer (LSO) back-up and as such manage, in absence of LSO, the medical safety of assigned GPV local products with under the supervision of the Regions Medical Safety Head (RMSH).

  • OPTION: Serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed)

 

Experience:

 

  • Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended

  • A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary

  • Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus

  • Experience with Regulatory Agency interactions

 

Soft skills:

  • Leadership, able to create networks and to collaborate in an international cross-functional environment

  • Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important

  • Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure

  • Ability to work in international and transversal teams.

 

Technical skills:

  • Robust knowledge of pharmacovigilance systems & regulations

  • Sufficient ability to interpret clinical data including safety data

  • Able to evaluate & manage safety signals and define risk management activities

 

Education:

  • Advanced health care discipline degree (M.Pharmacy, B.Pharmacy or MBBS.) or equivalent qualification with 5 Years Experience.

 

Languages:

  • Professional English language proficiency

 

 

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

 

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

 

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!