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Planet Pharma
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Objective of Position
The Medical Director encompasses a key role in contributing and executing on departmental deliverables and in managing the day-to-day functioning of the pharmacovigilance department.
Essential Duties/ Responsibilities
Objective of Position
The Medical Director encompasses a key role in contributing and executing on departmental deliverables and in managing the day-to-day functioning of the pharmacovigilance department.
Essential Duties/ Responsibilities
PV Medical Director
Posted: 06/12/2025
2025-06-12
2025-07-12
Employment Type:
Contract
Job Category: Pharmacovigilance
Job Number: 619705
Is job remote?: Yes
Country: United States
Job Description
Objective of Position
The Medical Director encompasses a key role in contributing and executing on departmental deliverables and in managing the day-to-day functioning of the pharmacovigilance department.
Essential Duties/ Responsibilities
- Conducts medical review oversight of SAEs in case processing workflow conducted by vendors to provide appropriate evaluation of clinical course, workup, causality, expectedness assessment, and queries for follow-up.
- Provide appropriate safety surveillance of incoming SAE reports in the context of the safety profile of the product under investigation.
- Ensures that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures
- Performs Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database
- Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as appropriate
- Liaises with assigned Physicians in Drug Safety, Medical Monitors in Clinical Development and others when needed, to ensure that appropriate medical review and assessment is provided for assigned case reports
- Participates in clinical data review in collaboration with Pharmacovigilance and Clinical Development
- Manages communications with partner companies, collaborative sponsors & respective CROs regarding the evaluation and processing of case reports
- Contributes to the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems
- Is the key point of contact for investigational product complaints after receipt of initial complaint providing assessment of any SAEs related to the product complaint and sends to Quality Assurance
- Assists Medical Director(s) in the analysis, identification and reporting or possible trends and concerns re: products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
- Contributes to the planning and preparation of the adverse events section of protocols and informed consents for clinical studies
- Ensures that the reconciliation of applicable safety DB data with external groups such as the DM staff for clinical studies; Drug Safety personnel from partner companies, etc. is governed by SOPs
- Oversees the preparation of ASURS, DSURs, IND Annual Reports, PSURs/PBRERs and other global periodic safety reports
- Participates in the development and review of appropriate safety sections of IBs, CSRs, ISS, & NDAs
- Minimum 10 years of drug safety, clinical research, or healthcare related experience
- A minimum of 2 years must be derived from pharmaceutical industry experience directly related to adverse event reporting from clinical trials
- Global experience is preferred. Oncology experience is a plus
- Detailed knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
- Minimum 5 years industry experience
- MD degree required
Objective of Position
The Medical Director encompasses a key role in contributing and executing on departmental deliverables and in managing the day-to-day functioning of the pharmacovigilance department.
Essential Duties/ Responsibilities
- Conducts medical review oversight of SAEs in case processing workflow conducted by vendors to provide appropriate evaluation of clinical course, workup, causality, expectedness assessment, and queries for follow-up.
- Provide appropriate safety surveillance of incoming SAE reports in the context of the safety profile of the product under investigation.
- Ensures that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures
- Performs Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database
- Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as appropriate
- Liaises with assigned Physicians in Drug Safety, Medical Monitors in Clinical Development and others when needed, to ensure that appropriate medical review and assessment is provided for assigned case reports
- Participates in clinical data review in collaboration with Pharmacovigilance and Clinical Development
- Manages communications with partner companies, collaborative sponsors & respective CROs regarding the evaluation and processing of case reports
- Contributes to the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems
- Is the key point of contact for investigational product complaints after receipt of initial complaint providing assessment of any SAEs related to the product complaint and sends to Quality Assurance
- Assists Medical Director(s) in the analysis, identification and reporting or possible trends and concerns re: products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
- Contributes to the planning and preparation of the adverse events section of protocols and informed consents for clinical studies
- Ensures that the reconciliation of applicable safety DB data with external groups such as the DM staff for clinical studies; Drug Safety personnel from partner companies, etc. is governed by SOPs
- Oversees the preparation of ASURS, DSURs, IND Annual Reports, PSURs/PBRERs and other global periodic safety reports
- Participates in the development and review of appropriate safety sections of IBs, CSRs, ISS, & NDAs
- Minimum 10 years of drug safety, clinical research, or healthcare related experience
- A minimum of 2 years must be derived from pharmaceutical industry experience directly related to adverse event reporting from clinical trials
- Global experience is preferred. Oncology experience is a plus
- Detailed knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
- Minimum 5 years industry experience
- MD degree required
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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