Director, Drug Safety at Organon

Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

12 Apr, 26

Salary

0.0

Posted On

12 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Medical Assessment, Device Safety, Regulatory Compliance, Signal Detection, Clinical Research, Team Leadership, Process Improvement, Metrics Development, Cross-Functional Collaboration, Adverse Event Reporting, Global Regulations, Medical Device Regulations, Diversity Support, Safety Monitoring, Audit Preparation

Industry

Pharmaceutical Manufacturing

Description

Job Description The Position The Medical Review and Device Safety Lead provides leadership in the areas of PV operations, medical assessment, device PV regulations, first-line signal detection, and innovation. The Medical Review and Device Safety Lead oversees the implementation and monitoring of processes to ensure operational and scientific consistency of the in-line medical assessment of individual case safety reports (ICSRs) in accordance with global PV regulations. The Medical Review and Device Safety Lead is accountable for the implementation of necessary processes to ensure compliance with global PV regulations related to medical assessment and device safety. This role is responsible for directing and overseeing a PV Medical Review team (in-house and outsourced), which supports these processes working cross-functionally to maintain standards for pharmacovigilance activities to ensure patient safety. Responsibilities Contributes to the development of and maintenance of comprehensive and compliant medical review and medical assessment processes to drive efficiency into the medical safety review business process, introducing automation where possible. Ensures implementation of new or updated regulations and/or ICH Guidelines regarding in-line medical assessment to ensure regulatory compliance for individual case safety reports. Provides in-line medical assessment of individual case safety reports in the context of the available safety data and the known safety profile to assess expectedness and formulate a company statement and a causality assessment as per timelines determined by OARS workflow. Provides in-line medical assessment of harm or potential harm associated with device or device-constituent to support individual case safety report (ICSR) reportability determination as per timelines determined by OARS workflow. Serves as the primary point of contact for in-line medical assessment of individual case safety reports and as subject matter expert for these topics during audits and inspections. Provides device legislation expertise in relation to medical review and medical assessment and reporting responsibilities. Consults with TA lead Clinical Development Safety and/or Clinical Research as needed for cases requiring additional safety or clinical subject matter expertise. Escalates potential safety issues to the attention of the Head Medical Safety Excellence and Safety TA Leads. Develops, maintains, and captures metrics and Key Performance Indicators (KPI) to track quality and compliance with PV regulations and timelines in collaboration with the relevant quality and compliance teams. Contributes to the preparation and responses to Regulatory Agency Inspections as well as internal and external audits. Tasks Provide input and review of responses to regulatory agency questions with regards to inline medical assessment of ICSRs Provide expert guidance on relevant PV activities outlined by procedures (SOPs, user manual, etc.). Lead and/or participate in cross-functional projects as the medical safety & device subject matter expert, contributing to continuous process improvement of ICSR assessments. Collaborate internally and externally on processes that ensure compliance with local and global PV regulations. Assess and implement emerging regulations to ensure global alignment of in-line medical assessment of individual case safety activities and processes. Participate in audit and/or inspection readiness activities and assists during the audit or inspection preparation, execution and CAPA resolution phase as needed as Subject Matter Expert. Participate in external benchmarking and industry working groups to drive change across the industry. Generate and track relevant metrics and KPIs. Required Education, Experience and Skills MD/DO/PhD or equivalent Ex US degree in Medicine with several years of pharmacovigilance and/or clinical experience exercising medical judgment as a physician ideally specialist in Woman’s Health, Internal medicine, or Pharmaceutical Medicine. Post-graduate qualifications in other areas are a plus. A minimum 7 years of work experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities Minimum of 5 years’ experience supervising/managing/leading Experience with vendor oversight Strong knowledge of clinical research process, pharmacovigilance processes and end to end process of individual case safety reporting for both clinical research and Post Marketing environments Strong knowledge of global PV regulations, in-depth understanding of business process, as well as safety systems for collections of adverse experiences Experience in global Medical Device regulations and device safety monitoring Experience working cross culturally and actively supporting diversity. Secondary Job Description Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. Search Firm Representatives Please Read Carefully Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites No Travel Required Flexible Work Arrangements: Remote Work Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.

Responsibilities

The Medical Review and Device Safety Lead oversees pharmacovigilance operations, ensuring compliance with global regulations and leading a team in the medical assessment of individual case safety reports. This role also involves developing processes for efficiency and quality in safety reporting.