Adverse Event SPOC

𝗧𝗵𝗶𝘀 𝗿𝗼𝗹𝗲 𝗶𝘀 𝗳𝗼𝗿 𝗼𝗻𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗪𝗲𝗲𝗸𝗱𝗮𝘆'𝘀 𝗰𝗹𝗶𝗲𝗻𝘁𝘀

𝗦𝗮𝗹𝗮𝗿𝘆 𝗿𝗮𝗻𝗴𝗲: 𝗥𝘀 𝟱𝟬𝟬𝟬𝟬𝟬 - 𝗥𝘀 𝟴𝟬𝟬𝟬𝟬𝟬 (𝗶𝗲 𝗜𝗡𝗥 𝟱-𝟴 𝗟𝗣𝗔)

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 cross‑functional teams, including clinical, medical, and regulatory to deliver high‑quality safety data. You will also mentor junior staff, contribute to continuous improvement initiatives, and support audits and inspections with strong analytical and communication skills.

𝗞𝗲𝘆 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀

• Serve as the Single Point of Contact (SPOC) for all adverse event reporting and processing activities.

• Receive, triage, and validate AE reports from healthcare professionals, patients, and internal sources.

• Complete detailed AE case narratives and enter data into the pharmacovigilance database in compliance with ICH‑E2B(R3).

• Perform signal detection, case clustering, and risk assessment using statistical tools and software.

• Liaise with regulatory agencies to submit mandatory safety reports (e.g., PSURs, SPCs, and PBRLs).

• Coordinate with medical and clinical teams to provide necessary clinical information and supporting documents.

• Conduct periodic audit preparations and support regulatory inspections, ensuring all data and documentation are ready.

• Develop and maintain standard operating procedures for AE handling and case management.

• Identify and recommend process improvements to enhance reporting accuracy and turnaround times.

• Mentor and train new hires on AE lifecycle, database use, and regulatory requirements.

𝗪𝗵𝗮𝘁 𝗠𝗮𝗸𝗲𝘀 𝗬𝗼𝘂 𝗮 𝗚𝗿𝗲𝗮𝘁 𝗙𝗶𝘁

• Bachelor’s or Master’s degree in Pharmacy, Medicine, Life Sciences, or related field.

• Minimum of 3+ years experience in pharmacovigilance with a focus on adverse event reporting.

• In-depth knowledge of ICH guidelines, MHRA, FDA, and EMA regulations.

• Proficiency in pharmacovigilance software (e.g., VigiFlow, Argus) and Microsoft Office Suite.

• Strong analytical skills with experience in signal detection and risk assessment methodologies.

• Excellent written and verbal communication skills in English.

• Ability to work independently and collaboratively in a fast‑paced environment.

• Detail‑oriented with a commitment to ensuring data integrity and regulatory compliance.

• Proven track record of managing multiple AE cases simultaneously while meeting deadlines.

• Experience in leading or mentoring junior pharmacovigilance staff.