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Safety Specialist

3 months ago

india Horizontal Talent Full time

Company Description


Since its formation in 2003, Horizontal Talent has been dedicated to delivering continual growth and has become one of the top 2% of all staffing companies worldwide. They specialize in matching exceptional talent with outstanding companies in various fields such as IT, marketing & creative, and business strategy. Whether it's finding great candidates or securing the perfect job, Horizontal Talent is committed to enabling businesses and helping the world work better.


Overview: We are seeking a highly skilled and experienced Safety Specialist to join our Pharmacovigilance team in the role of Manager. The ideal candidate will have extensive expertise in Pharmacovigilance, with a focus on Aggregate Report Writing including PSURs, PADERs, and PBRERs. This position requires a minimum of 6 years of relevant experience in the pharmaceutical industry.


Responsibilities:


  • Oversee and manage Pharmacovigilance activities related to safety reporting and signal detection.
  • Lead the writing and compilation of Aggregate Reports including Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), and Periodic Benefit-Risk Evaluation Reports (PBRERs) .
  • Ensure compliance with global regulatory requirements and guidelines pertaining to Pharmacovigilance.
  • Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, and Quality Assurance.
  • Provide mentorship and guidance to junior Pharmacovigilance staff.
  • Participate in risk management activities and contribute to risk minimization strategies.
  • Conduct literature reviews and analysis for safety signal detection and assessment.
  • Represent the Pharmacovigilance department in internal and external meetings as required.

Requirements:


  • Bachelor's degree in Pharmacy, Life Sciences, or related field; advanced degree (PharmD, PhD, or equivalent) preferred.
  • Minimum of 6 years of experience in Pharmacovigilance within the pharmaceutical industry, with a focus on Aggregate Report Writing .
  • In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH) for safety reporting.
  • Proven experience in leading and managing Pharmacovigilance projects and teams.
  • Excellent verbal and written communication skills, with strong attention to detail.
  • Ability to work effectively in a cross-functional and multicultural environment.
  • Strong analytical and problem-solving skills.
  • Prior experience with safety databases and other Pharmacovigilance software is preferred.
  • Certification in Pharmacovigilance (e.g., RAC, DIA) is a plus.