WhatsApp Group Join Now
Telegram Group Join Now

About Company

Sanofi is committed to pursuing progress and discovering extraordinary outcomes. We believe better medications, better outcomes, and better science come from diverse people working together. We provide equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.

Position Name :

PV Officer In Charge

Organization :

Sanofi

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

5 Years

Salary:

12.4 Lacs

Location:

Mumbai

  • Deputize for CSH: Replace the Country Safety Head (CSH) in their absence, act as local PV contact for authorities, and be accountable for PV inspections.
  • Compliance: Support the CSH in ensuring local PV activities comply with PSPV policies and global, regional, and local PV regulations to ensure safe use of Sanofi products.
  • System Maintenance: Assist in establishing and maintaining a robust and efficient local PV system, ensuring proper systems, procedures, tools, and training are in place.
  • Local Safety Officer (LSO): Optionally, manage the medical safety of assigned local products under the oversight of the Regional Medical Safety Head (RMSH).
  • Authority Liaison: Serve as the local PV contact for local authorities and act as the local Responsible Person for Pharmacovigilance (RPP) as required by country legislation.

Experience:

  • Pharmacovigilance Systems: Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products.
  • Minimum Experience: Experience in pharmacovigilance, regulatory, quality, medical, or clinical development.
  • Documentation Standards: Experience with high-quality safety documents such as RMP, PBRER is a plus.
  • Regulatory Interactions: Experience interacting with Regulatory Agencies.

Soft Skills:

  • Leadership: Ability to create networks and collaborate in an international cross-functional environment.
  • Interpersonal Skills: Diplomacy, team player dynamics, respect for cultural differences, professionalism, and mediation.
  • Problem Solving: Strong problem-solving skills and sense of urgency, particularly regarding safety rules and global procedures.
  • Pressure Handling: Ability to work under pressure and in international and transversal teams.

Technical Skills:

  • Pharmacovigilance Knowledge: Robust knowledge of pharmacovigilance systems and regulations.
  • Clinical Data Interpretation: Ability to interpret clinical and safety data.
  • Safety Management: Capability to evaluate and 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 of experience.

Languages:

  • Professional English language proficiency.

Application Link