- Provide comprehensive oversight of activities related to PSMF, including tracking of relevant pharmacovigilance processes and activities for compliance purposes, including but not limited to: quality surveillance, review of metrics, institution of any necessary additional monitoring (e.g., Corrective Action and Preventative Actions [CAPAs] and Quality Event deviations, assistance with product incident reviews and coordination of inspection readiness activities.
- Proactively develop and implement within PV department plans regarding quality, compliance and inspection readiness across Drug Safety & Pharmacovigilance department (both Clinical Safety & Postmarketing Pharmacovigilance)
- Attend cross-functional Safety Review Team meetings for in-depth product understanding of safety profile of Madrigal products to aid in quality review of pharmacovigilance system and documents
- Review and provide PV input for development and tracking of Postmarketing protocols, other relevant Postmarketing Commitments and key safety documents of interest
- Perform QC review of aggregate safety reports, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs) and other safety sections of key documents (including both internal only & regulatory submissions)
- Support vendor management regarding Qualified Person for Pharmacovigilance (QPPV) activities, including QPPV Project Plan
- Lead development and maintenance of Safety Data Exchange Agreements
- Provide subject matter expertise and input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with cross-functional areas as appropriate
- Degree in Pharmacy, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV or Clinical Drug Safety Monitoring
- Minimum 20 years of pharmaceutical industry experience, including a minimum of 15 years of working directly in pharmacovigilance, ideally with experience in both Postmarketing Pharmacovigilance and Clinical Safety
- Knowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases. Prior experience entering data and/or reviewing data within system a plus
- Thorough understanding of the drug development process and context applicable to safety surveillance activities
- Experience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical information
- Experience in the preparation and authoring of pre- and post- aggregate safety reports, RMPs and process documents
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Excellent communication skills and ability to influence across multiple functions
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Executive Director, Postmarketing Pharmacovigilance and Compliance - Conshohocken, United States - Madrigal Pharmaceuticals Corporation
Description
Job Description
Job DescriptionReporting to the SVP, Head of Clinical Safety & Postmarketing Pharmacovigilance, the Executive Director, Postmarketing Pharmacovigilance & Compliance will play a key role in management of the Pharmacovigilance System Master File (PSMF), including Compliance and Inspection-readiness activities. In addition, this role will serve as a mentor and resource for colleagues within the department and will assist as needed in key safety surveillance activities.Position Responsibilities:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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