Medical Safety Executive

Position:

Department:

Location:

Key Responsibilities

• Prepare and update Aggregate reports/ safety documents such as PADERs, PSURs, DSURs, RMPs, PBRERs, REMS, signal management documents and others, as applicable.
• Responsible for generation of applicable line listings from safety database, literature screening for inclusion, as applicable.
• Review and Identification of case reports and AOIs from literature and regulatory sources, as applicable.
• Independently creates and maintains Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), PMCF Reports and Summary of Safety and Clinical Performance [SSCP] for medical devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance documents and applicable procedures and templates.
• Creates and maintains PMS documents (PMS plan, PMSR, PSUR) and Risk management file for medical devices and combination products per Guidelines and company SOPs
• Maintain awareness of changes to regulations /new regulations affecting pharmacovigilance activities, as applicable.
• Train and mentor new employees/ existing employees in aggregate reports writing and other relevant pharmacovigilance activities, as applicable.
• Data retrieval from the safety database and EDC system, as applicable.
• Generate validated ad-hoc reports as well as periodic reports from the safety database, as requested.
• Provide inputs into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals), as applicable.
• Review of safety sections of protocol, clinical safety report etc., if required.
• Consults/ Communicates with multiple internal and external stakeholders (e.g. sponsor/ client/ medical monitor/ pharmacovigilance physician) to decide on an action and/or additional steps to provide complete narratives to the sponsor/client, as applicable.
• Conduct active follow-up for clarification and missing case details with reporter (e.g. site / clinical study team / HCP / patients / caregiver / literature authors, etc.), if required.
• Enter initial and follow-up information in the safety database according to the project requirement, if required.
• Perform coding for all required medical/drug/device term according to given coding dictionaries and applicable coding guidelines, as applicable.
• Perform/ co-ordinate expedited and periodic reporting according to project-specific requirements, as applicable.
• Responsible to maintain project-specific folders at shared drive as per the project requirements.
• Maintain PV related information and all correspondence in relation to Pharmacovigilance activities with agencies and customers based on signed agreements, as applicable.
• Participate in audits and regulatory inspections in cooperation with QA, as needed.
• Review and preparation of SOPs, WIs, Guides, training materials, providing inputs to SOPs, as applicable.
• Request or raise various templets (ADM, UAM, etc.) as per the requirement.
• Provide various quality and compliance related data/documents or any other data/ documents/ evidences required for the oversight and management of pharmacovigilance activities, as applicable.
• Other duties assigned by Manager/ COD Management/ Head - PV / Designee.

Qualifications & experience required

• Scientific Degree required. Advanced degree (M. Pharm, PharmD or PhD) desirable.
• Preferably over 3 to 4 years of experience working in Pharmacovigilance and/or Materiovigilance well versed with medical terminology
• Experience working with biopharmaceutical companies or Medical Device companies in the EU/ US regions
• Experience working on multiple product types such as vaccines, cell and gene therapies or medical devices
• Good understanding of applicable regulations such as ICH, GVP, MDR, US regulations