Assistant General Manager

1. Collaborates with the applicable global or local Quality Assurance (QA) staff and Pharmacovigilance (PV) staff to aid the audit planning process. Reviews audit findings to identify areas requiring improvements and inputs to and approves corrective action in conjunction with the Quality Assurance staff in order to achieve good pharmacovigilance practice & regulatory compliance.

2. To provide support and medical leadership for the assessment of all pharmacovigilance activities throughout the department. Assist in the development of appropriate Standard Operating Procedures, provide support to other members of the pharmacovigilance team as required. Implementation and maintenance of SOP and Working Instructions to and ensure that there are clear written procedures in place describing the MAHs pharmacovigilance system. Ensuring the establishment, maintenance and management of the MAHs pharmacovigilance system.

3. Acting as line manager for group leaders of medical review team, and signal management team and Aggregate MR team.

4. To ensure compliance (quality, procedures, regulations, timeliness, consistency) of all ICSR-Medical review and Signal reports in accordance to applicable regulatory and client requirements.

5. Provide required Input into SDEA, PMPs and PSMF. Having awareness of post-authorisation safety studies requested by the CDSCO including the results of such studies (If Applicable); Oversees preparation and maintenance of Pharmacovigilance System Master File in order to promote, maintain and improve compliance with the India requirements.

6. Review of SOPs, Wls, templates, guide and guidance training documents and Development of strategy and procedures for integrating cross functional team members and group leads of Medical review and signal management teams. Review of data entry, Drug coding, MedDRA coding and listedness. Assessment for expediting and narrative review of ICSR in accordance with Companys controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines. Medical Review of aggregate reports (PADER/PSUR/ACOS).

7. Contributing to the on-going enhancement of Pharmacovigilance processes and writing Standard Operating procedures.

8. Providing support for regulatory authority inspections and providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues.

9. Medical assessment of the safety profile of the clients product range and responsible for evaluation of Adverse Events and provide causality and provide guidance and participation in the follow-up of Adverse Events

10. Preparation, evaluation and management of risk management plan. Review of Clinical Expert Statements as per client requirement. Performing signal detection for clients medicinal product and to assess benefit risk balance of clients medicinal product.

11. Providing medical inputs/replying any medical inquiry and to identify any potential AE in product quality complaint(s) for all Lambda clients. Review of clinical trial protocol, preparation and review of safety management plans/pharmacovigilance management plans of clinical trial projects, medical assessment of SAE reported during clinical trial, discussion regarding SAE and its follow up.

12. Ensures availability for audits/inspections conducted by regulatory authorities regarding pharmacovigilance and for audits conducted by QA. Oversees review of global third party commercial agreements to ensure that the company products are adequately supported for pharmacovigilance reporting in accordance with national and international requirements. Review and sign off of Risk Management Plans (RMPs) 20) All persons involved in the review process must adhere to the timelines for reporting PSUR/RMP to regulatory authorities.

1. 10 + yrs. experience in Medical Reviewer & Signal detection is required.

2. Should have 5+ yrs team handling experience.

Education: MBBS/MD/BHMS/BAMS/BDS with experience.