๐ง๐ต๐ถ๐ ๐ฟ๐ผ๐น๐ฒ ๐ถ๐ ๐ณ๐ผ๐ฟ ๐ผ๐ป๐ฒ ๐ผ๐ณ ๐๐ต๐ฒ ๐ช๐ฒ๐ฒ๐ธ๐ฑ๐ฎ๐'๐ ๐ฐ๐น๐ถ๐ฒ๐ป๐๐
๐ฆ๐ฎ๐น๐ฎ๐ฟ๐ ๐ฟ๐ฎ๐ป๐ด๐ฒ: ๐ฅ๐ ๐ฑ๐ฌ๐ฌ๐ฌ๐ฌ๐ฌ - ๐ฅ๐ ๐ด๐ฌ๐ฌ๐ฌ๐ฌ๐ฌ (๐ถ๐ฒ ๐๐ก๐ฅ ๐ฑ-๐ด ๐๐ฃ๐)
Experience: 3+ yrs
Location: Bangalore, Mumbai
As a Adverse Event SPOC, you will serve as the primary point of contact for all adverse event (AE) matters within the organization, ensuring timely and accurate reporting to regulatory authorities and internal stakeholders. You will oversee the entire AE lifecycle, from initial signal detection through case processing and documentation, driving compliance with global pharmacovigilance regulations and internal SOPs. Your role will involve close collaboration with crossโfunctional teams, including clinical, medical, and regulatory to deliver highโquality safety data. You will also mentor junior staff, contribute to continuous improvement initiatives, and support audits and inspections with strong analytical and communication skills.
Requirements
๐๐ฒ๐ ๐ฅ๐ฒ๐๐ฝ๐ผ๐ป๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐ถ๐ฒ๐
โข Serve as the Single Point of Contact (SPOC) for all adverse event reporting and processing activities.
โข Receive, triage, and validate AE reports from healthcare professionals, patients, and internal sources.
โข Complete detailed AE case narratives and enter data into the pharmacovigilance database in compliance with ICHโE2B(R3).
โข Perform signal detection, case clustering, and risk assessment using statistical tools and software.
โข Liaise with regulatory agencies to submit mandatory safety reports (e.g., PSURs, SPCs, and PBRLs).
โข Coordinate with medical and clinical teams to provide necessary clinical information and supporting documents.
โข Conduct periodic audit preparations and support regulatory inspections, ensuring all data and documentation are ready.
โข Develop and maintain standard operating procedures for AE handling and case management.
โข Identify and recommend process improvements to enhance reporting accuracy and turnaround times.
โข Mentor and train new hires on AE lifecycle, database use, and regulatory requirements.
๐ช๐ต๐ฎ๐ ๐ ๐ฎ๐ธ๐ฒ๐ ๐ฌ๐ผ๐ ๐ฎ ๐๐ฟ๐ฒ๐ฎ๐ ๐๐ถ๐
โข Bachelorโs or Masterโs degree in Pharmacy, Medicine, Life Sciences, or related field.
โข Minimum of 3+ years experience in pharmacovigilance with a focus on adverse event reporting.
โข In-depth knowledge of ICH guidelines, MHRA, FDA, and EMA regulations.
โข Proficiency in pharmacovigilance software (e.g., VigiFlow, Argus) and Microsoft Office Suite.
โข Strong analytical skills with experience in signal detection and risk assessment methodologies.
โข Excellent written and verbal communication skills in English.
โข Ability to work independently and collaboratively in a fastโpaced environment.
โข Detailโoriented with a commitment to ensuring data integrity and regulatory compliance.
โข Proven track record of managing multiple AE cases simultaneously while meeting deadlines.
โข Experience in leading or mentoring junior pharmacovigilance staff.