Medical Director, Pharmacovigilance
Location: Massachusetts - Remote
Salary: $215,000-$250,000 + Bonus
A commercial stage biopharmaceutical company is seeking a Medical Director of Pharmacovigilance. It operates globally, focusing on unaddressed skeletal health needs. The firm collaborates resolutely to enhance patient and family lives. Its assets include commercial and clinical development, spanning mid to late-stage drug candidates.
This person will person will be in charge of global pharmacovigilance for the company's clinical and post marketed products including review and analysis of data from clinical trials, advising on project teams using their medical expertise, identify safety signals and manage the risk benefit section and review aggregate reports.
Duties and Responsibilities:
- Maintains an advanced understanding of safety matters, encompassing emerging concerns and the risk-to-benefit profile for relevant compounds. Also, upholds familiarity with regulatory directives in connection to drug safety and pharmacovigilance.
- Oversees the assessment of Individual Case Safety Reports (ICSR), ensuring the precision and completeness of safety information. This involves evaluating factors such as severity, predictability, and causal relationships, as well as coding, narrative summary review, and provision of case insights. Offers medical responses for further inquiry.
- Engages in collaborative efforts with individual project teams, delivering medical insights and expertise.
- Leads safety signal identification initiatives for designated products, and as required, discusses these signals within the context of the Safety Review Team (SRT).
- Plays an integral role in the creation and assessment of comprehensive reports (DSUR, PSUR, RMP, ad-hoc safety reports), including furnishing authoritative medical evaluations. Responsible for composing pertinent safety sections and weighing risk-benefit elements within aggregate safety reports.
- Supplies medical perspectives and safety-related inputs for inquiries from regulatory entities, IRBs, ethics committees, etc.
- Presides over the Safety Review Team (SRT) dedicated to the applicable products, coordinating effectively with varied internal and external stakeholders. This involves the management of newly surfaced safety signals from both post-marketing and clinical trial domains.
- Cultivates robust communication channels and fosters relationships with diverse stakeholders, including PV Vendors and Radius Partners, with a focus on pharmacovigilance matters.
- Sustains the updating and refinement of the benefit-risk assessment for assigned products across their lifecycle.
- Contributes to and assesses safety sections within study reports, protocols, consent forms, company core data sheets, investigator brochures, NDA/MAA clinical summaries, and product labeling.
- Participates in cross-functional and project-specific team gatherings, offering medical expertise when required.
- Achieves departmental goals by overseeing and guiding team members.
- Plans, arranges, and supervises departmental functions to ensure the attainment of objectives.
- Nurtures team members by strategically recruiting, selecting, orienting, and training personnel.
- Works collaboratively with team members to identify internal growth prospects.
- Sustains a continuous evaluation of team performance and provides guidance to enhance competencies and knowledge.
- Ensures adherence to all regulatory mandates and consults with human resources regarding matters of employee relations.
- Note: Some travel may be necessary for this role.
- MD or DO required
- 5 - 10 years of experience in the Pharmaceutical Industry within Drug Safety
- Direct experience with clinical practice preferred
- Experience in Global Drug Safety required
- Proficiency in ICH/FDA guidelines for GCP as well as for clinical and post marketing safety reporting
- Capacity for comprehending, examining, and interpreting scientific and technical literature
- Competence in evaluating and reviewing post-market and investigational events, along with the capacity to manage documentation and assessments for aggregate reports. Proficiency in drafting/overseeing Annual Reports, PSURs, and Type II Variations is essential.
- Familiarity with MedDRA coding and methods for retrieving case series data
- Adeptness in thriving within a dynamic work environment, showcasing the ability to manage numerous concurrent tasks and priorities
- Ability to collaborate with international partners and Contract Research Organizations (CROs)
- Possession of exceptional English writing skills and adept verbal communication, both in conversation and presentation
- Proven capabilities in decision-making and troubleshooting, coupled with a proactive mindset